Terminologies and General Concepts:

Before delving into specifics, it's essential to grasp key terminologies and general concepts surrounding specifications:

Specifications, as per GMP guidelines, is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria. EU GMP ICH Q6A- 3.1.1

Acceptance Criteria: are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a new drug substance or new drug product should conform to be considered acceptable for its intended use. EU GMP ICH Q6A- 3.1.1

Materials requiring specifications:

There should be appropriately authorized and dated specifications for starting and packaging materials, and finished products; where appropriate, they should be also available for intermediate or bulk products. EU GMP Eudralex Ch4- 10

Development:

When proposing specifications, thorough justification for each criterion is necessary.

The following points should be taken into consideration when establishing scientifically justifiable specifications.

•         Specifications are linked to a manufacturing process.

•     Specifications should account for the stability of drug substance and drug product.

•        Specifications are linked to preclinical and clinical studies.

•     Specifications are linked to analytical procedures.

EU GMP ICH Q6A- 3

The concept of different acceptance criteria for release vs. shelf-life specifications applies to drug products only; it pertains to the establishment of more restrictive criteria for the release of a drug product than are applied to the shelf-life. EU GMP ICH Q6A- 2.2

Review and approval:

The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. FDA 21 CFR 211- 22.C

Maintenance:

Periodic revisions of the specifications may be necessary to comply with new editions of the national pharmacopoeia or other official compendia. WHO TRS 986 Annex 2- 15.16

Changes:

Specifications, sampling plans, and test procedures, including changes to them, should be drafted by the appropriate organizational unit and reviewed and approved by the quality unit(s). EU GMP ICH Q7A-11.12

Conclusion:

Specifications play a pivotal role in ensuring the quality and safety of pharmaceutical and food products. By establishing clear standards and acceptance criteria, manufacturers uphold GMP compliance and regulatory requirements. Continuous review, approval, and maintenance of specifications are essential to adapt to evolving industry standards and ensure product integrity throughout its lifecycle.

References

1. ICH Q 6A - Specifications

2. FDA- 21 CFR – Part 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

3.WHO, TRS 986, Annex 2, WHO good manufacturing practices for pharmaceutical products: main principles

4. EudraLex, Volume 4, Part 1 Chapter 4: Documentation