GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process. To ensure that the products are absolutely fit for intended use, the company has to demonstrate in a documented form that the processes, methods, tests, activities and equipments they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions.

The validity can be established using following studies:

Prospective Validation – It is conducted before the new drugs are released into market or when the existing drugs are manufactured using a revised process and protocol. The authorities ensure prior to drug distribution that the characteristics of interest are functional and comply with the safety standards.

Retrospective Validation – Regulators need assurance from time to time that the drugs already being produced and distributed are of highly quality. They use historical data, batch records, documented evidences, log books, control charts, customer complaints and audit reports to perform validation. It can only be conducted for products or processes already in use.

Concurrent Validation – This form of validation is conducted during the normal process of manufacturing or services. The inspectors perform sample analysis for a chemical assay or to trace the impurities.

Types of Validation

Since almost all the aspects related to facilities, procedures, processes and activities are to be validated, the validation work has been categorized into following parts:

GMP Validation – An Important Tool Towards Safer World

1: Process Validation

FDA has mentioned the requirements for process validation in Section 820.75 of the Quality System Regulation (QSR). Performance of the process is inspected to obtain documented assurance that the manufacturing process successfully meets the pre-defined acceptance criteria. The activities in process validation that focus on machines, systems and equipments are called “qualifications”. They include: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification.

2: Cleaning Validation

Let’s say your company just finished manufacturing tablets for fever and will soon manufacture a batch of dysentery tablets using those same equipments. What if the residues of first batch couldn’t be cleaned properly and got mixed with the ingredients of the next batch? Got it? FDA conducts GMP validation for cleaning to ensure that no cross-contamination occurs between different batches.

3: Method Validation

Ensuring the precision, accuracy and consistency of analytical tests in very important. A test method must be verified to be acceptable for intended use before it is applied to test the analytical samples. The method has to reliably deliver the pre-established results under the defined conditions.

4: Computer System Validation

Adapting to the growing use of computer systems in pharmaceutical manufacturing, tissue culture establishments and clinical trials, FDA issued a guide especially for the inspection of computer systems in pharmaceutical industries. The guide was first published in 1983 and is commonly called ‘bluebook’.  Annex 11 was added to EU GMP regulations (EMEA) for the purpose of computer system validation.


Life Cycle of GMP Validation

1.     Validation master plan

2.     Validation protocol

3.     Execution of validation

4.     Validation report

5.     Preparation of SOPs

These five steps are the key to preparation, documentation and implementation of GMP validation for regulatory compliance.