Does ICH Q7 expect that the quality unit performs API release testing?

Does ICH Q7 expect that the quality unit performs API release testing?

While the quality unit has responsibility for the release of the API, which includes oversight of the testing and results, ICH Q7 does not prescribe specifically who performs testing.

There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization. The term quality control in the ICH Q7 refers to the activities, not the organizational structure.

Responsibilities of the Quality Unit(s):

The main responsibilities of the independent quality unit(s) should not be delegated. These responsibilities should be described in writing and should include but not necessarily be limited to:

  • Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the control of the manufacturing company;
  • Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials;
  • Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution;
  • Making sure that critical deviations are investigated and resolved;
  • Approving all specifications and master production instructions;
  • Approving all procedures impacting the quality of intermediates or APIs;
  • Making sure that internal audits (self-inspections) are performed; 
  • Approving intermediate and API contract manufacturers;
  • Approving changes that potentially impact intermediate or API quality;
  • Reviewing and approving validation protocols and reports;
  • Making sure that quality related complaints are investigated and resolved;
  • Making sure that effective systems are used for maintaining and calibrating critical equipment;
  • Making sure that materials are appropriately tested and the results are reported;
  •  Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and
  • Performing product quality reviews.

Product Quality Review:

Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:

  • A review of critical in-process control and critical API test results;
  • A review of all batches that failed to meet established specification(s);
  • A review of all critical deviations or non-conformances and related investigations;
  • A review of any changes carried out to the processes or analytical methods;
  • A review of results of the stability monitoring program;
  • A review of all quality-related returns, complaints and recalls; and
  • A review of adequacy of corrective actions.

The results of this review should be evaluated and an assessment made of whether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be completed in a timely and effective manner. 

The independent quality unit(s) should have at its disposal adequate laboratory facilities. 

All specifications, sampling plans, and test procedures should be scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels and packaging materials conform to established standards of quality and/or purity.

Specifications and test procedures should be consistent with those included in the registration/filing. There can be specifications in addition to those in the registration/filing. 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). 

Does ICH Q7 expect that the quality unit performs API release testing?

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