Contract Manufacturing (cGMP CMO) Compliance

Assessment for pharmaceutical contract manufacturing organizations covering cGMP compliance, quality agreements, and third-party oversight

PharmaBiotechMedtechContract-manufacturing minutes18 questions

1. Quality Agreements

Is a comprehensive Quality Agreement (QA) in place defining responsibilities?*

Quality Agreement: Manufacturing scope, QC testing, release authority, change control, deviation reporting, audit rights

Does QA clearly define material/product release authority and testing responsibilities?*

Release authority: Specify who releases raw materials, intermediates, finished product; QC testing responsibilities

Are regulatory filing responsibilities (DMF, MAA, NDA) clearly defined in agreements?*

Regulatory: Drug Master File (DMF) ownership, Manufacturing Authorization Application (MAA), inspection notifications

2. Vendor Qualification

Is CMO qualification performed with on-site audit before manufacturing initiation?*

Vendor qualification: Pre-approval audit, facility inspection, cGMP compliance review, quality system assessment

Are CMO regulatory inspection history and warning letters reviewed?*

Due diligence: FDA 483 observations, warning letters, consent decrees; assess corrective actions

Is CMO capacity and capability assessed for scale-up and commercial supply?*

Capacity assessment: Equipment suitability, batch size scalability, annual capacity, backup plans

3. Manufacturing Controls

Are validated manufacturing processes transferred with executed process validation protocols?*

Tech transfer: Master batch records, process parameters, validation protocols, analytical methods, specifications

Does CMO maintain equipment qualification (IQ/OQ/PQ) and calibration programs?*

Equipment qualification: Installation, Operational, Performance Qualification; annual calibration schedules

Are environmental monitoring and cleaning validation programs in place?*

Environmental monitoring: Viable/non-viable particulates, cleanroom classification; cleaning validation for multi-product facilities

4. Quality Oversight

Are batch manufacturing records reviewed by sponsor before product release?*

Batch record review: Complete documentation, in-process testing, deviations, OOS investigations before release

Are stability studies conducted per ICH guidelines with timely reporting?*

Stability: ICH Q1A (drug product), Q1B (photostability), Q5C (biologics); annual stability reports

Is retain sample program established with appropriate storage conditions?*

Retain samples: One year beyond expiration date, stored at labeled conditions, sufficient for full testing

5. Change Control & Deviations

Is change control system in place requiring sponsor approval for manufacturing changes?*

Change control: Prior written approval for equipment, process, facility changes; impact assessment, validation

Are deviations reported to sponsor within defined timeframes (e.g., critical within 24 hours)?*

Deviation reporting: Critical (patient safety, product quality), major (cGMP), minor; investigation timelines

Are CAPA (Corrective and Preventive Action) systems implemented for recurring issues?*

CAPA: Root cause analysis, corrective action, effectiveness check, preventive measures, trending

6. Audits & Inspections

Are periodic audits of CMO conducted at least annually?*

Audit frequency: Annual routine, for-cause (deviations, complaints), pre-approval; audit reports maintained

Are regulatory inspection notifications received and responses shared by CMO?*

Inspection transparency: FDA 483, EMA inspection reports, CMO responses, CAPA timelines

Is CMO audit observation trending performed to identify systemic issues?*

Audit trending: Track observation types, repeat findings, CAPA effectiveness, compare across CMOs

Please answer all required questions to see your results