| Checklist/checkpoints | Document to refer | Y/N/NA | Remarks | |
|---|---|---|---|---|
| • | Is there an SOP for writing, handling, and updating SOPs? | SOP for SOP | ||
| • | Are all documents passing through appropriate review and approval procedure? | Template of all document | ||
| • | Distribution records maintained for all documents? | Traceability of any specification/SOP | ||
| • | Is there any procedure for ensuring that the current version of the documents are being used? | Document distribution and retrieval record | ||
| • | Is responsibility assigned for issuance and control of documents? | Job description | ||
| • | Is history of changes made in documents maintained? | Document history record | ||
| • | Does document control procedure include the procedure for handling obsolete versions? | Traceability of compliance | ||
| • | Does the storage/archival of documents provide a suitable environment to minimize deterioration or damage to quality-related documents? | Archive | ||
| • | Is there a system for periodic review of documents? | Document review/revision SOP | ||
| • | Is there a document control system available? | Respective SOP | ||
| • | Are all quality-related documents being retained for history? | Superseded/obsolete document | ||
| • | Are corrections made in documents signed and explained? Does the SOP reflect this policy? | SOP for correction of entries | ||
| • | Are electronic signatures used? If yes, is there an adequate control or security measure? | SOP | ||
| • | Is equipment cleaning being recorded in the logbook? | Logbook | ||
| • | Is preventive maintenance activity being recorded in the logbook? Or is there any other appropriate documentation? | Preventive maintenance plan and logbook | ||
| • | Is RM available at the warehouse, labeled with the following details: | In RM store | ||
| - Lot No. | ||||
| - Receipt date | ||||
| - Approval/status label | ||||
| • | Are master labels retained? | BPR / BPCR | ||
| • | (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? | MPCR/MFC | ||
| -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? | MPCR and development report | ||
| • | Is there a system for identifying major equipment, instruments, and production lines? Is this information included in batch production and control records where appropriate? | MPCR and BPCR | ||
| • | Is there a system to determine customer requirements related to the product and supply of the product? | Policy and evident document | ||
| • | Is there a formal procedure to communicate the agreed upon customer requirements to the appropriate personnel? | SOP and evident document | ||
| • | 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? | Agreement | ||
| • | Is there a system to assure that any mutually agreed customer-initiated changes are promptly incorporated? | Agreement | ||
| • | 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? | Agreement | ||
| • | Does the batch record mention the following: | BPCR | ||
| -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? | Traceability at QC | ||
| • | Is method of analysis available with QC? | Traceability at QC | ||
| • | Is there an SOP for investigation of OOS? | SOP and evident document | ||
| • | Does the analytical report/COA mention the reference of STP used? | Analytical report | ||
| • | Is analysis being performed by qualified personnel? | Analyst and its qualification and copy of FDA approval | ||
| • | Are batch record and analytical records being reviewed by QA before dispatch? | SOP on batch release | ||
GMP: Good manufacturing practice, cGMP: Current good manufacturing practice, SOP: Standard operating procedures, QC: Quality control, MFC: Master formula card, MPCR: Master production and control records, BMR: Batch manufacturing record, BPR: Batch packaging record, BPCR: Batch production and control records, API: Active pharmaceutical ingredients, OOS: Out-of-specification, RM: Raw material, COA: Certificate of analysis, STP: Standard test procedure, QA: Quality assurance