Validation Practices for the Pharmaceutical Industry

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Italvacuum, Srl

Donadon SDD Srl

One should also consider the impact those systems might have on the accuracy, reliability, integrity, availability and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate it.

It is recommended that the decision should be based on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity. Furthermore, appropriate controls based on such an assessment should be incorporated. Audit trails can be particularly appropriate when users are expected to create, modify or delete regulated records during normal operation.

The objective of audit trail is:

• To check application commitments and verify authenticity and accuracy of data contained in submissions

• To assure that the product development was done justifying process attributes

• To ensure development facilities comply with GMP standards

• To ensure manufacturing facilities comply with GMP standards

• To ensure related controlled facilities (like water, clean steam, HVAC, gases, raw materials delivery, vendors etc) comply with GMP standards.

Referring to Table 1, one can see that companies have three options as to document its records for an audit. Option A requires one to maintain log reports over a considerably long time period and is cumbersome to adhere for validation. Option B is an improvement; however, there is considerable time and effort required in preparation to archival of the records. Option C is the latest and the most sophisticated solution.

Master Validation Plan for Pharmaceutical Production

The process validation of the system is documented based on the process parameters that are provided by the owner (refer Figure 1). However, the templates provided by the software vendor only aid in asset qualification and validation. The 21 CFR Part 11 validation plan includes compliance approach, organization, system validation, risk evaluation, system gap analysis and remediation. The software package supports Standard Operating Procedure (SOP) which needs to be worked as per the compliance approach by the client. The detailed, module covers internal as well as external expertise levels validation. The system validation covers various validations related to process and analytical know how and associated risks. In Gap Analysis, unaddressed requirements and program/module/interface – integrity documentation is tested.

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