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How do you adapt GMP requirements to different products, processes, and markets?

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Good Manufacturing Practice (GMP) is a set of standards and guidelines that ensure the quality, safety, and consistency of products in the pharmaceutical, biotechnology, food, and cosmetic industries. GMP covers all aspects of production, from the raw materials and equipment to the personnel and documentation. However, GMP is not a one-size-fits-all approach. Different products, processes, and markets may have different GMP requirements, depending on the regulatory authorities, customer expectations, and technical challenges. How do you adapt GMP requirements to different products, processes, and markets? Here are some tips to help you.

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1 Understand the regulatory framework

The first step to adapting GMP requirements is to understand the regulatory framework of the product, process, and market you are dealing with. Different countries and regions may have different GMP regulations, such as the EU GMP, the US FDA cGMP, the WHO GMP, and the ICH Q7. You need to know the specific GMP requirements of each jurisdiction, as well as the relevant harmonized standards and guidelines, such as the ISO, the ICH, and the PIC/S. You also need to be aware of any changes or updates in the regulations, and how they affect your product, process, and market.

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Sania M.

Leadership expert in QC/QA/QS & Regulatory Compliance in Biopharma, Biotechnology, Chemistry, manufacturing and controls industries.
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The first step to adapting GMP requirements is to understand the regulatory framework of the product, process, and market you are dealing with, however regardless of the finished product, one has to ensure that the laws and regulations on GMP is applicable no matter what. The safety, quality and integrity is at stake. Whether you fill a vial of injection or a carton of milk. The concept is same.

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2 Define the product specifications

The second step to adapting GMP requirements is to define the product specifications, such as the identity, purity, potency, stability, and performance of the product. The product specifications should be based on the intended use, the target population, the route of administration, and the dosage form of the product. The product specifications should also be aligned with the regulatory requirements, the customer expectations, and the scientific knowledge of the product. You need to establish the critical quality attributes (CQAs) and the critical process parameters (CPPs) that affect the product quality, and monitor them throughout the production process.

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Bob Pelley

Validation Engineer III
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The product specifications should also be based on capability, whether it's physical building, the equipment used for manufacturing or analysis, and the personnel. You cannot expect sterility as a specification if your site does not have sterile manufacturing capability and trained personnel who can manufacture under sterile conditions.

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3 Design the production process

The third step to adapting GMP requirements is to design the production process, such as the raw materials, the equipment, the facilities, the utilities, the personnel, and the procedures. The production process should be designed to meet the product specifications, the regulatory requirements, and the customer expectations. You need to apply the principles of quality by design (QbD) and risk management to optimize the production process, and ensure its robustness, efficiency, and reliability. You also need to validate the production process, and verify its suitability and reproducibility.

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Sania M.

Leadership expert in QC/QA/QS & Regulatory Compliance in Biopharma, Biotechnology, Chemistry, manufacturing and controls industries.
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Keep in mind that when we speak of validate, which is to ensure something is meeting its intended purpose and not to be confused with Qualification.

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4 Implement the quality system

The fourth step to adapting GMP requirements is to implement the quality system, such as the quality policy, the quality objectives, the quality manual, the quality procedures, and the quality records. The quality system should be implemented to ensure the compliance, traceability, and accountability of the production process. You need to follow the good documentation practices (GDP) and the good data integrity practices (GDIP) to maintain the accuracy, completeness, and availability of the quality records. You also need to conduct the internal and external audits, and address any non-conformities or deviations.

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Sania M.

Leadership expert in QC/QA/QS & Regulatory Compliance in Biopharma, Biotechnology, Chemistry, manufacturing and controls industries.
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Quality System also included Quality events associated with the life cycle of the finished product. Which starts with Supplier Initiation of change, to as mentioned of non-conformities or Out of Specification materials, to investigation and creating Corrective and Preventative Actions, Change Controls, Audits (internal/external), Document Control, Product complaints, and Annual Product Review

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Bob Pelley

Validation Engineer III
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A critical part of the quality system is training and documentation of the training. Also important is to have qualified personnel in the proper roles as defined in the job description and an individual's CV or resume.

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Richard Lasky, Ph.D.

CMC and Analytical Development Consultant for Biotech and Pharma Industry
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Another critical part of the GMP quality system are the analytical test methods for in-process, release and stability testing. Non-compendial methods should be fully validated by the time the program is getting ready for marketing application. The parameters that need to be included in the method validation vary depending on the type of method. There is a table in ICH Q2R1 that is a great guide for this. In addition, methods used in stability testing must had documentation that they are stability indicating. Along with the validation protocols and reports, the FDA will expect each non-compendial method to have a development report that shows the method optimization steps take to arrive at the final test method.

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5 Train the personnel

The fifth step to adapting GMP requirements is to train the personnel, such as the operators, the supervisors, the managers, and the quality assurance staff. The personnel should be trained to perform their roles and responsibilities in accordance with the GMP requirements, the product specifications, and the production process. You need to provide the initial and ongoing training, and assess the competency and performance of the personnel. You also need to foster a culture of quality awareness, commitment, and continuous improvement among the personnel.

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6 Review and improve

The sixth step to adapting GMP requirements is to review and improve the product, the process, and the market. You should review the product quality, the process performance, and the market feedback on a regular basis, and identify any opportunities for improvement. You should also implement any changes or improvements in a controlled and documented manner, and evaluate their impact on the product quality, the process performance, and the market satisfaction. You should also update the GMP requirements, the product specifications, and the production process as needed.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Sania M.

Leadership expert in QC/QA/QS & Regulatory Compliance in Biopharma, Biotechnology, Chemistry, manufacturing and controls industries.
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Enforcing GMP is similar to being in our own kitchen, making food and consuming them. Always have safety, standard and quality in our mind, for example: What if the meat isn't cooked thoroughly, then my child can get sick. What if the birthday cake I baked isn't the right color that my child requested, then it will bring disappointment. What if I don't clean the utensils or counter properly, then there is a risk of contamination. These are few examples where we apply personally day to day basis, applying the same concept to our work will optimize the understanding of why GMP rules and regulation as put in place.

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How do you adapt GMP requirements to different products, processes, and markets?

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1 Understand the regulatory framework

2 Define the product specifications

3 Design the production process

4 Implement the quality system

5 Train the personnel

6 Review and improve

7 Here’s what else to consider

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