Manostaxx
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SOURCE: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3122044/table/d32e1179/
| 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 |
| -Quantity |
| -Rationale |
| -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? |
