Audit Checklist for Quality Control Department in Pharma

The audit is an important aspect of determining the growth and market existence of any organization, particularly in the pharmaceutical sector. the success of an audit relies on multiple factors, some of the audit Audit Checklist for Quality Control are described below:

Audit Checklist for Quality control

1.0 Audit Checklist Quality Control Department

1.1 Does the QC lab have SOPs to cover all the functional areas?
1.2 Are adequate facilities and equipment available for the physical, chemical & microbiological testing?
1.3 Are approved written procedures available for sampling, inspecting, and testing raw materials, packaging materials, in-process drugs, bulk drugs, and finished products?
1.4 Are samples of starting material, packaging material, Intermediate products, bulk products, and finished products taken by methods and personnel approved by the QC department?
1.5 Are in-process materials tested at proper stages for identity, strengths quality, and purity, and are they approved or denied by Quality Control?
1.6 Are records of in-process controls maintained?
1.7 Does each batch of drug product prior to release confirms compliance with finished product specification?
1.8 Are validated & stability-indicating assay methods used?
1.9 Are reference standards used for the assay?
1.10 Are accurate, clear & neat records maintained along with the raw data for the entire analytical work?

Related: Audit Checklist for Human Resource

Each point of the checklist shall be filled as applicable and comments or remarks, in addition, shall be given under the remarks column in the checklist.

Note: The facts cited in this list are not limited to these only

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