SCHEDULE M READINESS ASSESSMENT — COMPLETE SYSTEM
Does your facility have a documented Pharmaceutical Quality System (PQS) that goes beyond a set of SOPs — covering quality objectives, management responsibilities, and continual improvement?
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Does your facility have a documented Pharmaceutical Quality System (PQS) that goes beyond a set of SOPs — covering quality objectives, management responsibilities, and continual improvement?
Does your senior management (MD/Plant Head) conduct formal quality review meetings at defined intervals — with documented decisions, not just data presentations?
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Does your senior management (MD/Plant Head) conduct formal quality review meetings at defined intervals — with documented decisions, not just data presentations?
Does your facility maintain a Training Needs Matrix — a document that defines what specific GMP training each role requires?
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Does your facility maintain a Training Needs Matrix — a document that defines what specific GMP training each role requires?
After each GMP training session, do you conduct a written competency assessment — and retain the results as part of the training record?
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After each GMP training session, do you conduct a written competency assessment — and retain the results as part of the training record?
If a CDSCO inspector walked to your production floor right now and asked any operator to explain what they do when they find a mistake in their batch record — would your operators give a complete, correct answer without hesitation?
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If a CDSCO inspector walked to your production floor right now and asked any operator to explain what they do when they find a mistake in their batch record — would your operators give a complete, correct answer without hesitation?
Are all entries in your batch records made at the exact time the action is performed — not at the end of the shift or during batch record review?
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Are all entries in your batch records made at the exact time the action is performed — not at the end of the shift or during batch record review?
Is correction fluid (whitener) completely absent from all GMP documentation areas in your facility?
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Is correction fluid (whitener) completely absent from all GMP documentation areas in your facility?
When deviations occur in your facility, are they reported to QA within the same shift — and investigated to identify a root cause beyond "human error"?
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When deviations occur in your facility, are they reported to QA within the same shift — and investigated to identify a root cause beyond "human error"?
For every CAPA your facility has closed in the last 12 months — is there a documented effectiveness check confirming the deviation did not recur?
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For every CAPA your facility has closed in the last 12 months — is there a documented effectiveness check confirming the deviation did not recur?
Has your facility conducted a formal self-inspection (internal audit) against Revised Schedule M requirements within the last 12 months — with findings documented and CAPAs assigned?
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Has your facility conducted a formal self-inspection (internal audit) against Revised Schedule M requirements within the last 12 months — with findings documented and CAPAs assigned?
When your facility makes significant changes — to a process, equipment, or procedure — is a documented risk assessment completed before the change is implemented?
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When your facility makes significant changes — to a process, equipment, or procedure — is a documented risk assessment completed before the change is implemented?
Does your deviation register include a root cause category column — and do you review deviation trends quarterly to identify recurring patterns?
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Does your deviation register include a root cause category column — and do you review deviation trends quarterly to identify recurring patterns?
Are electronic data sources — balance printouts, HPLC data, temperature charts — retained with the corresponding batch records, and do your electronic systems have audit trails that are never disabled?
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Are electronic data sources — balance printouts, HPLC data, temperature charts — retained with the corresponding batch records, and do your electronic systems have audit trails that are never disabled?
Has your QA team reviewed the full Revised Schedule M document (December 2023 notification) and mapped your current facility operations against its requirements — formally and in writing?
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Has your QA team reviewed the full Revised Schedule M document (December 2023 notification) and mapped your current facility operations against its requirements — formally and in writing?
Does your facility conduct an annual Product Quality Review (PQR) for each product — including trend analysis of in-process and finished product data, not just data compilation?
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Does your facility conduct an annual Product Quality Review (PQR) for each product — including trend analysis of in-process and finished product data, not just data compilation?
