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Is there an SOP for writing, handling, and updating SOPs?
Are all documents passing through appropriate review and approval procedure?
Distribution records maintained for all documents?
Is there any procedure for ensuring that the current version of the documents are being used?
Is responsibility assigned for issuance and control of documents?
Is history of changes made in documents maintained?
Does document control procedure include the procedure for handling obsolete versions?
Does the storage/archival of documents provide a suitable environment to minimize deterioration or damage to quality-related documents?
Is there a system for periodic review of documents?
Is there a document control system available?
Are all quality-related documents being retained for history?
Are corrections made in documents signed and explained? Does the SOP reflect this policy?
Are electronic signatures used? If yes, is there an adequate control or security measure?
Is equipment cleaning being recorded in the logbook?
Is preventive maintenance activity being recorded in the logbook? Or is there any other appropriate documentation?
Is RM available at the warehouse, labeled with the following details:
– Lot No.
– Receipt date
– Approval/status label
Are master labels retained?
(For all lots that are packed and supplied, master labels should be part of Batch Packaging Record (BPR) or be separately filed)
Does the MPCR/MFC mention the following details?
-Name of material, with code
-Equipment to be used
-Process parameter
-In-process checks
-Sampling instruction
-Expected yield
Have process parameters critical to quality been defined and, if parameters are exceeded, is the affect on quality known?
Is there a system for identifying major equipment, instruments, and production lines? Is this information included in batch production and control records where appropriate?
Is there a system to determine customer requirements related to the product and supply of the product?
Is there a formal procedure to communicate the agreed upon customer requirements to the appropriate personnel?
Is there a procedure in place to assure that the manufacturer and the customer have mutually agreed upon the specifications and other requirements? If not, what is the alternative process?
Is there a system to assure that any mutually agreed customer-initiated changes are promptly incorporated?
Is there an adequate system in place to assure that significant process changes, including the use of subcontractors and their effect on the product, are communicated to the customer?
Does the batch record mention the following:
-Deviations, if any
-In-process results
-Release statement
-All details should match with MPCR
Are specifications for all material available with QC and user department?
Is method of analysis available with QC?
Is there an SOP for investigation of OOS?
Does the analytical report/COA mention the reference of STP used?
Is analysis being performed by qualified personnel?
Are batch record and analytical records being reviewed by QA before dispatch?

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