GMP and Validation

GMP is an abbreviation for the Good Manufacturing Practice standards that were published by the United States Food and Drug Administration under the jurisdiction of the Federal Food, Drug, and Cosmetic Act in 1986. As part of these standards, which have the weight of law, it is mandated that medication makers, medical device processors and packagers, as well as some food and blood producers, take proactive measures to guarantee that their goods are safe, pure, and effective.

GMP validations need a quality-oriented approach to production, which enables organisations to reduce or completely eliminate instances of contamination, mixups, and mistakes during the manufacturing process. 

GMP Validation

It is a quality assurance programme component for a pharmaceutical/biotech product or process to validate Good Manufacturing Practices (GMP). To guarantee that the goods are totally fit for their intended purpose, the firm must demonstrate in written form that the processes, techniques, tests, activities, and equipment that it employs can generate the required product consistently, as recorded by the company. As a result, each essential step in the manufacturing process must be thoroughly tested to ensure that it operates as intended under specified conditions.

The use of the following studies may demonstrate the validity of the study:

Prospective Validation is carried out before introducing new medications onto the market or when current drugs are produced utilising a redesigned method and procedure. Before distributing a medicine, the authorities check to see if the qualities of interest are functioning and that the drug meets all applicable safety regulations.

Why is this necessary? 

• It is necessary to introduce new products into the production plant.
• It is necessary to report a substantial change in the manufacturing process and the impact of the change, for example, if a leak test fails to owe sealing difficulties in a blister package is required.
• This validation should be performed on a minimum of three consecutive production size batches following process stabilisation.

Retrospective validation: Regulations need assurance from time to time that the pharmaceuticals that are currently in production and distribution are of good quality. This is known as retrospective validation. Validation is carried out using historical data, batch records, recorded proof, logbooks, control charts, customer complaints, and audit reports. It can only be carried out on items or processes that have already been used.

Concurrent Validation – This type of validation is carried out while the usual process of producing or providing services is being carried out. The inspectors conduct sample analysis to perform a chemical test or trace the presence of contaminants.

Types of Validation in the Pharma Sector

1: Process Validation

Section 820.75 of the Quality System Regulation, published by the FDA, outlines the standards for process validation (QSR). The process is examined to ensure that the manufacturing process fulfils the predetermined acceptance criteria, the process is examined. As a part of process validation, “qualifications” refer to operations that focus on machines, systems or other equipment. Qualitative tests comprise the following: Design Qualifications, Installation Qualifications; Operational Qualifications; and Performance Qualifications.

2: Cleaning Validation

You recently finished making pills for fever, and now you’re going to make dysentery tablets using the same equipment.? What if the first batch’s residues couldn’t be thoroughly cleansed and ended up in the second batch’s ingredients? Have you grasped the gist? The FDA undertakes GMP validation for cleaning to verify that no batch-to-batch cross-contamination occurs.

3: Method Validation

Analytical tests need to be precise, accurate, and consistent. Before testing analytical samples, a test technique must be proven to be suitable for its intended purpose. Under the specified conditions, the procedure must consistently provide the expected outcomes.

4: Computer System Validation

The FDA published guidance specifically for the inspection of computer systems in pharmaceutical companies in response to the increased use of computers in pharmaceutical manufacture, tissue culture establishments, and clinical trials. First released in 1983, the handbook is known as the “bluebook.” In order to validate computer systems, EU GMP standards (EMEA) included Annex 11.

The significance of GMP validation in the pharmaceutical industry

GMP Validation is critical in the pharmaceutical industry for the following reasons:

1. Quality assurance: Because of the limited availability of samples and the inability to test final products in the daily routine, it is not possible to ensure product quality by testing.  
2. Cost savings are achieved through the use of the validation process, which reduces the number of sampling and testing procedures and the number of product rejections and retesting procedures.
3. If the equipment is used in accordance with the manufacturer’s requirements, its life will be significantly extended.
4. Validation is required in order to maintain conformity with cGMP standards.a

Conclusion 

This technique authorises documentation to evidence that verifies the following process/method or activity will consistently create the product that leads to the intended outcome. It is also known as validation (predetermined requirements). The validation programme in the pharmaceutical industry includes a number of components that are connected to processing, cleaning, facilities, equipment, or instruments, among other things. Equipment validation has been a regulatory obligation for pharmaceutical businesses in recent years and it must be completed prior to the certification of new equipment/instruments. Meanwhile, the validation process necessitates an in-depth understanding of the instrument that is to be verified.