[aid]

How to request a GMP inspection from FDA?

[Pharma Digests]

To apply to market a new drug, biologic, or an antibiotic drug for human use (including NDA & ANDA), firstly you need to complete Form 356h.

Form 356h include: submission date, applicant information, product description, NDA/ANDA application number etc.

After successful filing your product, FDA will conduct application based GMP inspections to ensure the facility is capable of manufacturing the product consistently and that submitted data are accurate and complete.

[aid]

What are the most critical check points for pharmaceutical manufacturing facilities to face FDA GMP audit?

[Pharma Digests]

Few critical check points for pharmaceutical manufacturing facilities to face FDA GMP audit:
– SOPs are up-to-date with practice
– Deviations and CAPAs
– Previous audit observations
– Data integrity
– Cleaning validation

[aid]

Thanks Pharma!

[FRD]

What areas of a pharmaceutical industry fall under the scope of FDA GMP inspections?

[Pharma Digests]

@FRD
Areas under FDA GMP (Good Manufacturing Practices) inspection:
1. Facility and Equipment
– Facility Design (layout, space, cleanliness)
– Equipment design, maintenance, calibration, and cleaning
– Utilities (qualification of water systems, HVAC, and other utilities critical to production)

2. Materials Management
– Proper sourcing, testing, and storage of raw materials
– Tracking and reconciliation of materials
– Supplier Qualification

3. Production and Process Controls
– Standard Operating Procedures (SOPs)
– Process Validation
– In-Process Controls
– Batch Records

4. Quality Control and Testing
– Adequate testing of raw materials, in-process materials, and finished products
– Established quality standards for materials and products
– Evidence that products remain within specifications throughout their shelf life
– Proper handling and investigation of OOS results

5. Packaging and Labeling
– Label Control
– Packaging Integrity
– Expiry Dating

6. Documentation and Recordkeeping
– Batch Records
– Deviations
– Change Control
– Training Records

7. Self-Inspection and Audits
– Internal Audits
– CAPA Managements

8. Complaint Handling and Recall Procedures

9. Data Integrity
– ALCOA+ Principles
– Electronic Records

10. Quality Risk Management (QRM)

[Author]

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