Industry News

The Basics of current Good Manufacturing Practices (cGMP)

A set of guidelines for the manufacture, processing, packing, distribution, and storage of medicines. GMP stands for Good Manufacturing Practices.

The FDA ensures the quality of drug products by closely monitoring drug manufacturers’ adherence to Current Good Manufacturing Practices (cGMP) requirements. The cGMP regulations for medications establish minimal standards for the procedures, facilities, and controls used in the production, processing, and packaging of a drug product. The rules ensure that a product is safe to use and that it contains the ingredients and strength that it promises.

“Good practices in production and quality control” outlines steps that should be taken independently by production and quality control staff to implement the general QA standards.

Medicines must comply with GMP guidelines in the following ways:

Are of consistent high quality are suitable for their intended use; and comply with the marketing approval or clinical trial authorization standards.

“Quality management in the pharmaceuticals industry describes the general principles of quality assurance (QA) as well as the major components or subsystems of GMP, which are shared duties of top management and production and quality control management. Hygiene, validation, self-inspection, staff, premises, equipment, supplies, and documentation are some of these.

The cGMP inspection report mostly cover the inspection of all portions including premises, equipment, documentation, materials, validation, sanitation, hygiene, production, quality assurance and utilities.

“Good practices in production and quality control” provides guidelines on actions that production and quality control people should perform individually to implement the general principles of QA. Quality assurance (QA), good manufacturing practices (GMP), quality control (QC), and quality risk management (QRM) are all interrelated components of quality management that should be the responsibility of all personnel.

QA is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. QA, therefore, incorporates GMP and other factors, including those outside the scope of this guide such as product design and development. The system of QA appropriate to the manufacture of pharmaceutical products should ensure that: (a) pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice

(GCP); as those of good laboratory practice (GLP)73 7 and good clinical practice (GCP); (b) production and control operations are clearly specified in a written form and GMP requirements are adopted; (c) managerial responsibilities are clearly specified in job descriptions; (d) arrangements are made for the manufacture, supply and use of the correct starting and packaging materials; (e) all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out; (f) the finished product is correctly processed and checked, according to the defined procedures; (g) pharmaceutical products are not sold or supplied before the authorized persons (see also sections 9.11 & 9.12) have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products; (h) satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life; (i) here is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the QA system; (j) deviations are reported, investigated and recorded; (k) there is a system for approving changes that may have an impact on product quality; (l) regular evaluations of the product quality; (l) regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement; and (m) there is a system for QRM.

To achieve the quality objective, there must be a comprehensively designed and correctly implemented system of Quality Assurance. This should incorporate both Quality Assurance and Quality Control. The Quality Systems must be fully documented and its effectiveness monitored.

All parts of the Pharmaceutical Quality Assurance program should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment and facilities. 1.4 QRM is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. 1.5 QRM should ensure that: — the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient; and — the level of effort, formality and documentation of the QRM process is commensurate with the level of risk.

GMP is that part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular of unexpected contaminants) and mix ups (confusion) caused by, for example, false labels being put on containers. Under GMP: (a) all manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications; (b) qualification and validation are performed; (c) all necessary resources are provided, including: (i) appropriately qualified and trained personnel;

(ii) adequate premises and space; (iii) suitable equipment and services; (iv) appropriate materials, containers and labels; (v) approved procedures and instructions; (vi) suitable storage and transport; (vii) adequate personnel, laboratories and equipment for in-process controls; (d) instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided; (e) operators are trained to carry out procedures correctly; (f) records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected; any significant deviations are fully recorded and investigated; (g) records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; (h) the proper storage and distribution of the products minimizes any risk to their quality; (i) a system is available to recall any batch of product from sale or supply; (j) complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect.

Sanitation and hygiene 3.1 a high level of sanitation and hygiene should be practiced in every aspect of the manufacture of medicines products. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programmed of sanitation and hygiene. (For Personal hygiene see section 11, and for sanitation see section 12, “Premises”.) 4. Qualification and validation 4.1 In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled. 4.2 The key elements of a qualification and validation programmed of a company should be clearly defined and documented in a validation master plan.

Qualification and validation should establish and provide documentary evidence that: (a) the premises, supporting utilities, equipment and processes have been designed in accordance with the requirements for GMP (design qualification or DQ); (b) the premises, supporting utilities and equipment have been built and installed in compliance with their design specifications (installation qualification or IQ); (c) the premises, supporting utilities and equipment operate in accordance with their design specifications (operational qualification or OQ); (d) a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (process validation or PV, also called performance qualification or PQ).

Guidance on good data and record management practices

“If it isn’t documented, it didn’t happen,” as the saying goes in the pharmaceutical industry.

As a result, pharmaceutical and medical device industries document every thing to provide written proof that something occurred.

As a result, effective documentation practices, often known as GDPs, are crucial. The only official, documented record of:

 • processing a batch

• producing a device

• Final decision to release (or reject) a batch or product

• Evidence for a corrective or preventive action (CAPA)

• An investigation of manufacturing deviations, complaints, or alleged product defects

• meeting product and quality specifications generated from test is also, in addition to regulatory requirements.

The “history/storyline” of manufactured products and devices is told through records, reports, and procedures.

In addition to meeting regulatory requirements, it is critical to keep accurate records for commercial purposes. You can take a critical look at numerous processes associated to product manufacture with the goal of improving quality, product, or cost savings by keeping clear, accurate, and timely records.

Everyone who documents activities connected to cGMP or current Good Manufacturing Practices is subject to GDPs.

Good Documentation Practices are required to comply with the Food and Drug Administration’s GLP (Good Laboratory Practices) requirements (21 CFR Part 58), as well as GMP (Good Manufacturing Practices) regulations for medicines and medical devices (21 CFR Parts 211 and 820).

What types of documents require following Good Documentation Practices?

Some examples include:

• Analytical Methods

 • Batch Records

• Bills of Materials (BOMs)

• Certificate of Analyses (CoA)

 • Certificate of Compliance (CoC)

 • Laboratory Notebooks

• Policies

• Protocols • Quality records

• Standard Operating Procedures

• Test Methods

 • Training Documentation

• Validation Documents (IQs, OQs and PQs)

 • Work Instructions

• Product and Sample Labels Categories of Documents

1. Primary records such as those obtained from the master formula, manufacturing and packaging instructions.

 2. Supporting procedures such as instructions on how to perform a manufacturing step or test methodology.

3. Subsidiary records which support the process as it is being carried out, such as environmental monitoring or preventive maintenance/calibration on process or lab equipment. 4. Quality control records include all lab testing results for the process or products and al investigative reports and records.

Organizations that develop, manufacture, package, test, distribute, and monitor pharmaceutical products have mainly depended on the knowledge of regulatory systems around the world. 

The information submitted in dossiers (CTD) and used in day-to-day decision making is thorough, complete, and trustworthy data.  As a result, the information on which these decisions are based must be comprehensive, widely attributed, readable, current, original, and correct, commonly referred to as “ALCOA”. 

  • A: Attributable
  • L: Legible
  • C: Contemporaneous
  • O: Original
  • A: Accurate

ALCOA-plus. A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”, which puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.

Increased regulatory knowledge and concern about gaps between industry choices and acceptable and modern control procedures are only a few of the reasons why health authorities are becoming increasingly concerned about data reliability.

Intense attention has been put forward on good data and record management practices (GDRP) during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practices (GLP) because of increasing concern of health authorities regarding data reliability to meet the standards of desired pharmaceutical product and clinical practices.

Data management strategies must include Quality Risk Management (QRM) strategy that ensures patient safety, product quality, and data validity by ensuring that management aligns expectations with real process capabilities. Management should assume responsibility for good data management by first establishing realistic and achievable expectations for the realistic and existing capabilities of processes, methods, environments, individuals, and technologies, among other things.

Management’s monitoring of processes and allocation of necessary resources to ensure and improve infrastructure as needed (for example, to continuously improve processes and methods, to ensure adequate design and maintenance of buildings, facilities, equipment, and systems; to ensure adequate reliable power and water supplies; to provide necessary training for personnel; and to allocate necessary resources to the oversight of contract sites and suppliers to ensure and improve infrastructure as needed).

A planned set of controls that ensures protocol compliance, process performance, product quality, and data dependability, if appropriate, based on current protocol, test article and process understanding. Study subjects, test systems, product materials and components, technologies and equipment, and operating circumstances should all be included in the controls.

The activities done to improve an organization’s operations and reduce causes of non-conformities or other undesirable events are referred to as corrective action and preventative action (CAPA). CAPA is a notion that may be found in the GXPs (good laboratory practices, good clinical practices, and good manufacturing practices) as well as a number of business standards from the International Organization for Standardization.

The method focuses on a systematic analysis of the root causes of identified problems or risks in order to prevent recurrence (for remedial action) or the occurrence of such problems or risks (for preventive action).

The Importance of Pharmaceutical Quality

Pharmaceutical quality assurance is a dynamic practice, a state of mind or an understanding of the guidance as well as rules and regulations related to the manufacturing and development of pharmaceutical goods and products.

Pharmaceutical quality is an element of high-quality management riveted to guarantee and generate accurate and reliable outcomes on all laboratory activities undertaken. Drugs which are marketed should be safe as well as therapeutically active. The performance must be predictable as well as consistent. Or it can be defined as the result of all activities and responsibilities needed to make sure that the drug or product that reaches the consumer is effective and safe to use or take.

The System of Pharmaceutical Quality Assurance

This department is broken down into four important areas: Production, Quality Control, Distribution as well as Inspections. 

  • Pharmaceutical quality makes sure the arrangements are created for the manufacture, supply, and application of the correct starting and packaging materials. 
  • Any divergence from the written production and process control practices that are followed in the execution of different products as well as process control functions must be reported, investigated, and recorded by the quality department. 
  • Divergences from the established time restrictions for the completion of every stage of production must be justified as well as recorded by the pharmaceutical quality assurance department. 
  • The quality department should approve the activities involved in the process of manufacturing, bulk testing, and in-process control. 
  • The department does all the required control in intermediate goods as well as any other in-process controls and corroboration. 
  • High quality improvement plans
  • Technology transfer and validation 
  • Review stability date as well as the lifespan of the products 
  • The quality team often performs periodic Good Manufacturing Practice training to staff at all levels of the organization. 

Pharmaceutical Quality Assurance Objectives

The objective of pharmaceutical quality assurance takes account of the following:

  • Ensure that every medicine or device reaching a consumer or user is effective and safe as well as of standard quality.
  • Incurring medicament, which is effective and secure.
  • Assuring the quality of a product from selection to application
  • Persistent products that are effective and safe in structured selection as well as buying methods.
  • Exerting products in right storage, distribution, monitoring, as well as use techniques or methods. 

Conclusion

Pharmaceutical assurance quality does its very best in maintaining the reliability at each stage or level of manufacturing procedure begging from research, quality control, clinical studies, production, distribution as well as offers information on the right application and analyzes safety and product information. 

Pharmaceutical quality will also help in the strategic development and direction of quality systems, document control plans as well as standard operating procedures to make sure with the firm’s rules and regulations or policies and regulatory requirements. 

It’s a multi-fold activity in which all the industries need professionally competent, qualifies, skilled managerial as well as entrepreneurial talent labor to lead the pharmaceutical industry.  In general, Pharmaceutical Quality is a necessary element of drug development in the undersized pharmaceutical world.

Good Documentation Practices FDA

Good documentation practices are essential to adhere to the regulations of the FDA. It is among the key GMP compliance components. Companies should practice good record-keeping to help them on regulatory inspections.            

Good Documentation Practices are guidelines that companies adapt in recording raw data entries in a traceable, legible, and reproducible way. The key to Good Documentation Practices is to ask questions:

  • Is it accurate?
  • Is it true? 
  • Is it legible?
  • Is it timely? 

FDA mandates all companies in the industry to document their products to meet the standards and legal requirements for efficacy, safety, and product quality. The following are the basics of GMP for good documentation practices. 

Data validation/ integrity 

  • True, genuine data
  • It needs to be relevant to the reporting requirement
  • Supported and validated/ witnessed vs. intentionally falsified
  • Not changeable after the entry of original record-keeping

Data accuracy 

  • Cross-checked for errors
  • Accurately recorded
  • Not intentionally misleading to avoid editable entries, fraudulent entries

Reporting/ record-keeping timeliness

  • Real-time record keeping like date stamps
  • Data is recorded synchronously
  • Avoid errors from memory issues and editing of original data

Legibility 

  • Legible (readable by anyone)
  • Clarity
  • Readily accessible

Identifiable 

  • Records which can identify the individual who records the data
  • Watch for new technology adaptations for GDocP as the systems change
  • Blockchain can be discussed as part of Pharma 4.0 innovations
  • Given growing concerns about cosmetic medicines and counterfeit pharmaceuticals and fake antibiotics and substandard medicines that enter global pharmaceutical chains
  • GDP and GMP mandate no shared passwords

Document types for Good Documentation Practices 

The following are some documents that need to follow Good Documentation Practices:

  • Logbooks
  • Protocols
  • Analytical methods
  • Certificate of Analyses (CoA)
  • Laboratory notebooks
  • Policies
  • Batch records
  • Standard operating procedures
  • Product and sample labels
  • Training documentation
  • Test methods and more

Document categories 

Primary records

These are obtained from packaging and manufacturing instructions and master formulas. 

Subsidiary records

These records support processes as it as carried out, like preventive maintenance/ calibration on lab equipment or process. It also includes environmental monitoring. 

Supporting procedures

It can include instructions for performing a test methodology or manufacturing step.

Quality control records 

These records involve lab testing results for the products or processes. It also includes investigative records and reports. 

Importance of documentation 

In the pharmaceutical market, it didn’t happen if it isn’t documented. So, documentation is essential in the pharmaceutical and medical device market to offer written proof of something that happened. 

Good documentation practices are important. It includes reports and records associated to production events that show the official documented record of:

  • Production of a device
  • Processing a batch
  • Final decision to release or reject a product or batch
  • Complaints or alleged product defects, investigation of manufacturing deviations
  • Evidence of preventive or corrective action
  • Meeting quality and product specifications generated from test results

Conclusion 

To sum it up, failure to comply with FDA Good Documentation Practices can be a FDA or TGA audit failure finding. All organizations in the industry should stay updated with the requirements and compliance monitoring with good documentation practices. These include contractors, employees, vendors, and distribution-chain personnel (transport drivers, warehouse employees, transportation, delivery, storage, packaging, and production workers).

Good documentation practices should also be implemented to maintain the good reputation of companies with their customers.  

What is GMP and What does it Mean?

Are you not familiar with GMP? This article will guide you. GMP means Good Manufacturing Practice regulations, which the Food and Drug Administration promulgates in the US. With these regulations, the law mandated processors, manufacturers, and packagers of medical devices, drugs, some food, and blood take proactive steps to ensure that their products are effective, pure, and safe. 

In addition, GMP regulations demand a quality approach for manufacturing. With this, companies can eliminate or reduce instances of mix-ups, contamination, and errors. It is essential so the consumer will not purchase dangerous or ineffective products. 

What will happen if firms fail to comply with GMP regulations? 

If firms fail to comply with GMP regulations, they may be subjected to serious consequences such as seizure, recall, jail time, and fines. GMP also addresses problems like personal qualifications, record-keeping, cleanliness, sanitation, process validation, equipment verification, and complaint handling. 

Meanwhile, GMP is sometimes referred to as “cGMP,” wherein “c” means ‘current’ that reminds manufacturers to employ up-to-date systems and technologies to adhere to the regulation. 

Why are GMP regulations important?

GMP focuses on manufacturing procedures to avoid possible risks like adulteration, mislabeling, and cross-contamination. FDA regulates cGMP and needs to be followed by companies. 

Keep in mind that Good Manufacturing Practices are an essential system that needs to be implemented by all manufacturing facilities. Those who follow GMP standards can have assurance for their products’ quality, strength, and identity. 

GMP regulations are important since they can reduce waste and facility losses. Additionally, it can protect consumers, companies, and the environment against harm. With these regulations, companies can earn more and keep the trust of consumers. Thus, it can convince consumers that their purchased products are made in well-regulated environments, safe, and adheres to government standards. 

Factors in manufacturing practices for GMP 

The following are factors to consider in GMP manufacturing practices:

Quality management 

Quality management focuses that the manufactured products perfectly suit their intended use. Companies should avoid expired, raw, and improper processes to prevent contamination or ham against harm.

Hygiene and sanitation 

Hygiene and sanitation are crucial, especially for cosmetic, drug, and food manufacturers. It covers everything which can result to contamination. 

Equipment 

The facility should also have clean equipment. The equipment should be located, designed, and maintained based on the correct procedures. Malfunctioning or defective equipment should be removed. 

Location of facility 

FDA also stated that manufacturing facilities need to be in a suitable location, away from contamination risks. 

Raw materials 

GMP also enforces that production materials need to be store properly. Additionally, there should be a proper inventory of the raw materials, including the source of materials for quality assurance. 

Personnel

GMP also ensures that facility personnel is qualified and well-trained. 

Handling complaints 

Companies are required to have a GMP-compliant system and prepared solutions. 

Qualification and validation

The steps of the manufacturing procedure need to have validation to adhere to GMP qualification guidelines. 

Documentation and record-keeping

Documentation and record-keeping are also essential for GMP. The documents need to be in legible and clear ways. 

Quality audits and inspections 

With regular audits and inspections, facilities can comply with GMP properly. 

To sum it up, adhering to GMP is essential to all companies for the safety of everyone. 

What Does GMP Stand For?

Poor-quality medicines and medical devices are not only a health hazard, but they are also a waste for both individual consumers and the government. Fortunately, GMP comes into play.

Many countries only accept the sale and import of medicines that have been manufactured under GMP guidelines. Most governments seek to promote their countries’ pharmaceutical exportation by making GMP mandatory for all production.

GMP is necessary for the quality control laboratory. After all, good quality is primarily built during the manufacturing process. GMP helps avoid errors that are impossibly be eliminated through the final product’s quality control. Without it, it is impossible to ensure that every medical device or medicine unit is of similar quality as the unit tested in the laboratory.

What is GMP 

GMP stands for Good Manufacturing Practice, promulgated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. These regulations require that packagers, processors, manufacturers of blood, some food, medical devices, and drugs take proactive steps to ensure safety, purity, and efficacy in their products.

With GMP regulations, a quality approach to the manufacturing process is required. This enables many companies to reduce and even eliminate cases of errors, mixups, or contamination. In return, consumers are protected against purchasing ineffective or dangerous products. If companies fail to comply with the GMP regulations, they are subjected to serious consequences, such as fines, seizures, recall, and jail time.

GMP Requirements 

Through the GMP regulations, issues like compliant handling, process validation, equipment verification, cleanliness, sanitation, personnel qualifications, and record-keeping are appropriately addressed. 

Most of the GMP requirements are open-minded and very general. This enables every manufacturer to decide about the best way to implement critical controls. Besides providing flexibility, the manufacturers must interpret the requirements where the methods make sense for every business.

Importance of GMP 

GMPs are an essential system that every manufacturing facility should implement. These regulations help ensure proper design, control, and monitoring of the manufacturing facilities and processes.

Companies should adhere to GMPs to ensure the quality, strength, and identity of each product. Once implemented, these standards help minimize the facility waste and losses. GMPs also help protect the environment, consumers, and companies from harm.

The FDA has set the Current Good Manufacturing Practices (cGMP) that gives manufacturers from different industries a set of standards. These standards help many manufacturing facilities gain and maintain the trust of their consumers who want to know and ensure that the products they buy are safe and well-regulated to the government standards.

Additionally, GMPs in food industry manufacturers are continuously becoming critical nowadays. That is because of the increasing cases of food recalls. Plus, more and more consumers are becoming more aware of food safety. They expect that the companies are taking vital steps to increase their accountability while delivering safe products, and recalls would not happen.

Conclusion 

Regardless of the manufacturing facility type, GMP plays a vital role in running the facility. Being a GMP compliant means that the facility makes a strong effort in creating a high-quality, sanitary, and safe environment for a safe and top-notch quality product creation.

QA Roles and Responsibilities in Pharmaceuticals

Quality assurance (QA) is one of the critical fields in the pharmaceutical industry which ensure that pharmaceutical products are being manufactured to a consistent and safe standard.

QA ensures that the products offer quality and safety. The documentation is QA’s main function, but it also controls the manufacturing system with regard to manufacturing quality products.

Quality Assurance Overview 

Quality assurance refers to a broad field that affects the medical product’s quality during different phases: research, development, manufacturing, and sales. A QA professional handles the instituting of the different practices that ensure the drug’s quality. 

This field emphasizes that the products’ safety, efficacy, and quality attributes are essential to guarantee that the consumers’ health is not compromised. It also reveals that consistency in manufacturing and delivery results to zero-defect products.

Roles and Responsibilities 

Nowadays, the pharmaceutical environment changes quickly due to supply chain, product or process complexity, international regulation development, demands for efficiency, cost constraint, increased competition, and globalization. For such an environment, pharmaceutical companies should adapt to these changes to prosper and provide the products that the consumers demand.

Ensures Medical Products Work As Intended and Safely 

Any defective medical products or do not work as intended presents a serious threat to public health. So, any QA departments of pharmaceutical companies ensure that any product is safe and effective.

QA departments utilize different methods and procedures to achieve that goal. For instance, QA professionals will conduct a test to know the drug stability, measuring the consistency of the product’s chemical, physical, therapeutic, and other properties remain in a specific condition and over time.

Stays Compliance with the Law 

QA helps many pharmaceutical companies to stay compliant with the law. With the massive impact of pharmaceutical products and QA on public health, they have become highly regulated. Companies should comply to many rules and laws before that they can sell and market their products.

QA professionals are responsible for assisting the companies with regard to regulatory compliance. Then, the companies must be familiar with the Good Manufacturing Practices (GMP), a series of measures that every drug manufacturer should comply with. That way, they can ensure that the drugs are manufactured to a reliable and consistent standard.

Maintain Reputations 

Every consumer demands an assurance that the drugs they take are effective, quality, and safe. Once a pharmaceutical company is found out to be non-compliant with the QA guidelines or created products that are ineffective and unsafe, the consumers will lose trust and faith in the products’ quality.

That is why pharmaceutical manufacturers should ensure that they comply with all the QA regulations. This will not only help them gain the trust of the public about their products’ quality but also their brand as a whole. 

Conclusion 

QA has always been a critical field in pharmaceutical manufacturing. It does not only ensures that the companies are producing quality products but also safe. So, the public will have peace of mind knowing that the drugs they take are safe and effective. Plus, the products will not negatively impact their overall health.

What is GMP vs cGMP

When manufacturing products, it is vital to pay attention to the quality needs or requirements. Many regulatory and board authorities make sure manufacturers conform to the guidelines which protect the consumers. The United States FDA has created good manufacturing methods recorded under GMP and cGMP. They sound the same, and people often interchange the two, but there are some differences between the two.

What is GMP?

GMP or Good Manufacturing Practice is a method which very essential in a manufacturing facility. GMP guidelines make sure the safety as well as the quality of the products.

What is cGMP?   

The c in cGMP means current, so it follows the steps of the GMP, even if each utilizes the most present method. This is because of the continual innovation of good manufacturing practice standards. As policies improve, food manufacturers can make sure their goods are produces utilizing the current regulations. On the other hand, standard good manufacturing practice procedures are a safe way to follow, too.

What are the Differences Between cGMP and GMP?

While the most considerable difference is the application of the most current standards, there are other distinguished differences between cGMP and GMP.

  • Quality   

Both cGMP and GMP manufacturing create superior and high-quality results. Each follows rigid guidelines that make the purest, safest as well as superior products. On the other hand, with cGMP pharmaceuticals, goods manufacturer has gone to the greatest lengths to make sure the quality and safety of the products are meeting the needed standards. GMP goods still follow the right guidelines; however, cGMP goes a step further by utilizing the latest rules and regulations.

  • Availability

There are many uses of GMP than the cGMP. That is largely due to some of the manufacturers don’t utilize the newest or modern technology available because of the cost implications and availability. According to the research, there are over 100 different nations in the world that utilize GMP. On the other hand, just a handful of countries adhere to the rules and regulations of the cGMP.

  • Applicability

Good Manufacturing Practice is extensively applicable to a wide number of conditions in the world if compared to cGMP. These uses span a huge number of industries too. Like for instance, Good Manufacturing Practice is utilized in making sure different aspects of a business that takes account of making sure cleanliness, bookkeeping, meeting personnel qualifications as well as manufacturing equipment. Also, Good Manufacturing Practice is utilized to classify quality in procedures followed by a company or business. On the other hand, the cGMP applicability is limited. It can largely be utilized for manufacturing products.

  • Fee or Rate  

cGMP utilizes the latest technology to adhere to new manufacturing methods; thus, it is likely to be costly than GMP. Goods that follow cGMP also undergo lots of testing to make sure the right application of the manufactured products and to make sure pharmaceuticals quality. All additional testing, as well as innovative technology, makes cGMP an expensive option. 

No matter what method you utilize, both cGMP and GMP is a vital facet of manufacturing.

Investigation Tools in Pharma

There are multiple investigation tools in pharma to choose from, including impact assessment, medical opinion, review of complaint history, fish bone diagram, and brainstorming.

What are their differences? Which is the best investigation tool to use in pharmaceuticals? Your long wait is finally over! This guide got your back!

Brainstorming

Brainstorming is where people meet to generate ideas, solutions, opinions, and suggestions to solve a particular problem.

People can think freely and suggest new ideas that may put an end to any adversary. But, more than that, brainstorming is used in pharma to build enthusiasm, engagement, loyalty, and commitment.

It also unlocks and stimulates an individual’s creative talents. Plus, it can develop and strengthen self-esteem.

In any group, the leader should be well-versed in questioning. Some of the possible questions to ask are the following.

–What has happened to the medical product?

–When was the defect realized?

–What was the patient’s current situation?

–What are the probable causes that have resulted in this deviation or defect?

You can also think of any other queries to gather more ideas and suggestions.

Fish Bone Diagram

After brainstorming, a fish bone diagram is utilized.

Commonly called a case and effect diagram, this technique was popularized by Kaoru Ishikawa in the 1960s. Ishikawa is the one who pioneered the management system in the Kawasaki shipyards.

This investigation tool is sometimes referred to as the Ishikawa diagram.

Like the fish bone, the head represents the defect. The major causes of the problem are the ribs. There also sub-branches under each cause. This is how it looks like.

Root Cause

Based on the root cause in the fish bone diagram, you can perform the five whys. It is a tool in which people ask why until they arrive at the best answer to the problem.

The five whys is usually a discussion between teams. Each team consists of experts on quality assurance, process development, quality control, manufacturing, and engineering.

The five whys is used in problem solving, troubleshooting, and quality improvement.

It is developed by Sakichi Toyota, the founder of Toyota Industries, in the 1930s. But it only has gained massive popularity in the 1970s.

Decades had passed, the technique is still used today.

To utilize the method, it is vital to assemble a team, define the problem, ask Why at least four times, determine when to stop, overcome the root cause, and monitor the measures.

Review the Complaint History

A lot of people may not consider the past defect or deviation report. Do not do the same thing. Be sure to include every detail about the complaint history for your reference. Then, identify the root cause of the defect and other crucial information.

Medical Opinion and Impact Evaluation

Ask what will be the effect of a defective product to every patient and assess the impact. From there, you can come up to a conclusion finally.

When creating conclusions, ensure to include the root causes, review of complaint history, a recommendation to the patients, and other details if the need arises.

So, what’s your choice? Whatever it is, you can be confident you can solve a specific problem with a 100% success rate.

ICH Analytical Method Validation

The International Committee on Harmonization makes ICH Guidelines for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH’s main goal is to provide uniform standards for pharmaceuticals for technical requirements. The pharma industry and regulatory authorities create these guidelines.             

ICH Guidelines are essential to ensure safe, top-quality, and effective medicines are registered and manufactured efficiently. Regulatory authorities adopt these guidelines all over the world.   

Analytical method validation 

Validation of analytical methods can be subjected to the following analytical procedures.

Quantitative test for the content’s impurities  

Limit tests for impurities control

Identification tests

Quantitative tests of active group in drug substance samples or other chosen drug product components       

Identification tests are aimed to ensure the analyte’s identity in a sample. It can be done through the comparison of sample property to a reference standard.

Testing for impurities can be a limit test or a quantitative test for the sample’s impurity. The test aims to reflect the sample’s purity characteristics accurately. 

Assay methods are aimed to measure the existing analyte in a specific sample. 

Validation Characteristics for Analytical Methods

The following are the validation characteristics needed to be evaluated in analytical procedures. 

Precision

Precision presents the quality of agreement in a group of measurements from different sampling of a similar homogeneous sample of prescribed conditions. This characteristic can be considered in three levels: intermediate precision, repeatability, and reproducibility. 

Repeatability  this precision signifies under similar operating conditions within a short time. It is also called intra-assay precision. 

Intermediate precision – it presents laboratories variations: various equipment, days, analysts, and more. 

Reproducibility – it is the precision of laboratories. 

Accuracy

The analytical method’s accuracy presents the closeness of agreement between the value accepted as a reference value, conventional true value, and the value found. 

Detection limit

It is considered as the lowest analyte amount in a sample that can be identified but not necessarily quantitative in the exact value. 

Specificity

It is the assessment of unequivocally the presented analyte of components. It may include degradants, impurities, matrices, and more.  

Quantitation limit

It is characterized by an analytical method is the lowest analyte amount in a sample. It can be identified  quantitatively using suitable accuracy and precision. In addition, it is the quantitative assays parameter for those compounds with low levels in given matrices. 

Range 

The range is the interval between the lower and upper concentration analyte amount in a sample. It can demonstrate that the analytical method comes with a suitable accuracy, precision, and linearity. 

Linearity 

It is the ability to get test results proportional to analyte’s concentration in a sample.    

Conclusion 

Analytical method validation is important for ICH guidelines. The characteristics mentioned above are essential for the validation of analytical procedures. With ICH guidelines, potential risks can be identified and prevented to harm people. 

ICH guidelines are crucial for the manufacturing of top-quality medicines. With this, the products are registered and created efficiently. So, the products will be delivered in the best possible quality that will ensure the safety and efficiency of medicines. 

Data Integrity SOP In Pharmaceutical Industry

Data integrity is essential in the pharmaceutical industry to ensure products’ quality, efficacy, and safety. In today’s modern generation, pharmaceutical companies use computers and automated systems for generating data. With this, regulatory bodies require companies to comply with data integrity. Meanwhile, in this post, we will discuss data integrity SOP.

What is SOP?   

SOP stands for Standard Operating Procedures. It is a written procedure of any system or process followed on an equipment or system operation. SOPs in the pharmaceutical industry is essential for quality control, quality assurance, utility, maintenance, production, and human resource. 

Why is data integrity SOP necessary? 

Data integrity SOP is vital to ensure public health. It is also beneficial to ensure that the pharmaceutical products are safe, quality, and effective. With the help of data integrity SOP, pharmaceutical companies can also improve their data security. 

Practicing data integrity also helps to establish trust between the companies and regulatory agencies. It removes the requirement for inspecting each process in the supply and production of drugs and other pharma products. 

Data integrity SOP features 

When it comes to data integrity SOP, the data should have the features below:

The data should be offered in an understandable way and should be kept in general language.

It should be free from automated or human errors.

The data should be contemporary and fits the place’s time zone.

The data should be plagiarism-free and original.

It should be reflective, complete, and truthful.

How to integrate data in the pharmaceutical industry? 

Companies can integrate data through the following ways:

Data should be stored safely to avoid deterioration, loss, and theft.

Data should be safe, and no one is allowed to delete, modify or disturb it.

Data should record a complete assessment of the performed test without failure to record anything.

Data should be maintained in original records, true copies, and accurate reproductions with credits. 

Standard Operating Procedure (SOP) outlines the Handling of Data Integrity Observations procedure to ensure that observations are documented, identified, concluded, and investigated properly with the implementation of preventive/ corrective actions that can reduce or eliminate chances of similar issue recurrence. 

Important considerations for data integrity 

Data integrity should be kept in manual or system-generated electronic data. The data needs to be accurate and complete without alterations. If there are identified data integrity issues, they should be handled by the quality management system and the right corrective and preventive action for risk assessment. 

The data should be approved and verified by an expert technical person. Data should adhere to ALCOA rules: attributable, legible, contemporaneous, original, and accurate. It also needs to be complete and readable. Instruments with audit trials need to be reviewed daily before data approval. Additionally, it should be checked for any abnormality. 

Proper training on data usages and the integrity of computer systems need to be provided to all responsible personnel. Date integrity SOP is also important in the pharmaceutical industry to comply with the regulatory requirements. 

Conclusion 

Data integrity SOP helps provide accurate, complete, and consistent data in the pharmaceutical industry to sum it up. It helps to comply with the regulations, recalling products, and enhancing the reputation of a company in the industry.