Good Manufacturing Practice (GMP) Assessment

Do you have a formally documented Quality Management System (QMS)?*

QMS must include quality policy, procedures, and quality manual

Is there a designated Quality Unit independent from production?*

21 CFR 211.22 requires independent quality oversight

Do you conduct management reviews of the QMS at least annually?*

Are deviations investigated, documented, and subject to CAPA?*

Corrective and Preventive Action (CAPA) system required

Are all personnel qualified by education, training, and experience for their assigned functions?*

Do you provide GMP training to all employees with documented records?*

Initial and ongoing GMP training required per 21 CFR 211.25

Are personnel health evaluations conducted to prevent product contamination?*

Health screening for communicable diseases and open lesions

Do you enforce gowning requirements and hygiene practices in manufacturing areas?*

Are manufacturing facilities of suitable size, construction, and location to prevent contamination?*

21 CFR 211.42 facility design requirements

Do you maintain adequate lighting, ventilation, and environmental controls?*

Temperature, humidity, and air quality monitoring required

Is all equipment qualified (IQ/OQ/PQ) and subject to preventive maintenance?*

Installation, Operational, Performance Qualification required

Are equipment cleaning procedures validated and documented?*

Cleaning validation prevents cross-contamination

Do you test or obtain Certificates of Analysis (COAs) for all incoming raw materials?*

21 CFR 211.84 requires identity testing at minimum

Are raw materials, in-process materials, and finished products stored under appropriate conditions?*

Quarantine until released by Quality Unit

Do you maintain a material traceability system (lot/batch records)?*

Are all manufacturing operations performed according to written, approved procedures?*

Master Batch Records and executed Batch Records required

Do you perform in-process controls and testing during production?*

Critical parameters monitored and documented

Are processes validated to demonstrate consistent production of quality products?*

Process validation per FDA guidance (lifecycle approach)

Do batch records include complete documentation of all manufacturing steps and deviations?*

Do you perform laboratory testing on each batch per specifications before release?*

Identity, strength, quality, purity testing required

Are laboratory test methods validated per ICH guidelines?*

Accuracy, precision, specificity, LOD, LOQ validation

Do you maintain stability programs for all products?*

Ongoing stability to establish expiration dating

Are Out-of-Specification (OOS) results investigated per FDA guidance?*