QAS-012 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 284

attachment b

SOP No.:

Issued on:

Revision No.:

Initiator name:

INTERNAL QA AUDIT

Team members: , .

Dosage forms: , .

Products: , .

Batch No.: , .

Part I: PRODUCT-BASED AUDIT

a. Selection of products from different dosage form, one batch each from

• Tablet •Syrup

•Capsule •Suspension

•Cream •Drops

•Ointment •Suppository

•PPS •Injection

Batch selected with the batch No.

b. Review of (selected) batch documents and related SOPs

∙

Completeness

∙

Yield calculation

∙

Correctness

∙

Any nonconformance and their disposition

∙

Clarity

∙

Any deviations from standards

∙

Adequacy

∙

Consistency accuracy

∙

Batch documents complete with respect to raw materials, packaging commodity, and fin-
ishing supplies issues. Manufacturing procedure and all other documents duly signed
complete with product and materials reconciliation, and yield calculation. If any devia-
tion, it should be complete with corrective action.

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