Basic requirements for Process Validation exercises

The pharmaceutical industry is the highly regulated industry in the world. Every pharmaceutical manufacturing company has to face various audits by the Drug department and other players. To comply with the requirements of audits companies have to prove that the manufacturing of drugs is being under proper conditions and in the supervision of qualified personnel. The manufacturing processes are valid and the record of their validation is checked at the time of audit. 

The main objective of process validation is to manufacture products in required attributes and quality in a consistent manner. Process validation is done periodically to rule out any possible error in the manufacturing process.

The process validation requires for the manufacturing of the following categories of drugs:

• Human drugs

• Veterinary drugs

• Biological and biotechnology products

• Finished products and active pharmaceutical ingredients (APIs or drug substances)4

• The drug constituent of a combination (drug and medical device) product 

Each pharmaceutical manufacturing unit is bound to manufacture good quality products and the quality of products should be maintained consistently. To meet the objective of producing quality products, the safety of human health the manufacturing process validation is done. 

It is a very important aspect of quality assurance that the drug product is safe, pure, and has efficacy for the disease that it is intended to be used for.

Importance of Process Validation in Pharmaceutical companies.

It is very necessary to know that all manufacturing, weighing, analysis, and packing machinery are working in their desired conditions. While working for months robustly some machinery gets some deviation in their performance that slight deviation can lead to manufacturing a sub-quality product. Therefore, process validation is very necessary to find the processing error in the whole manufacturing process. 

For example, if the weighing machine in the IPQA is not providing true information about the product being manufactured that can leads to the manufacturing of a substandard product. In the same manner, any other machinery or equipment used in the manufacturing process can also have the same impact on the quality of drug products.

To eliminate the possibility of error in the manufacturing process, Process Validation is a very essential part of the pharmaceutical company.

ALSO READ: MHRA guidelines for quality manufacturer of pharmaceutical formulations

Some basic requirements for Pharmaceutical Process Validation

There are few things that are basic requirements for process validation that are listed below:

  • Functioning of equipments should be smooth and in range that are used in Process Validation
  • The proper documentation and registers should be established before starting the process validation
  • All other supporting equipment should be calibrated and performing in the specified limits.
  • Analytical methods for the process should be adopted and valid in respect of all references.
  • Preventive maintenance programs for equipment and instruments should be put in place.
  • Process variables should be determined that are leading to the establishment of the ranges of operation.
  • Important steps should be noted down before starting validation.
  • The area should be clean where the process validation is carried out.
  • Cleaning of equipment should be completed before performing process validation.

Various stages of Process Validation

During the manufacturing of a product many small and big activities take place, to conclude a process validation main three stages are important that is:

  • Stage-I Process design: This stage covers all activities related to the product research, formulation activities and product development.
  • Stage-II Process Qualification: During stage-II, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing
  • Continued Process Verification: In this stage ongoing assurance of quality is achieved that the process can remain in the controlled state. 

Factors affecting Process Validation

Any successful process validation plan depends on the out of information retrieved from the product and process development. All these knowledge and outcomes help to develop a process that can produce a consistent quality product that will fit in desired requirements. While doing process validation following aspects should remain in the mind of every evaluator:

  •  Understand the sources of variation
  •  Detect the presence and degree of variation
  •  Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product 

Every pharmaceutical company is bound to follow every concept of validation acceptable by the FDA. Process validation clears the hurdles of the possible error and improves the quality of drug products. The authentic documentation of process validation helps to prove that your working process of manufacture is of standard parameters. This also helps you for further CAPA activities if any. The quality management system can find some insights from the process validation. 

BUY: How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology) Book.


  • Process Validation: General Principles and Practices-FDA
  • Biopharmaceutical Manufacturing Process Validation and Quality Risk Management-ISPE
  • Annex 4-Supplementary guidelines on good manufacturing practices:

Darshan Singh

The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.
× How can I help you?