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GMP Requiments

The document outlines essential requirements for facility design, personnel training, documentation, production control, quality control, materials management, validation, complaint handling, and self-inspection in a manufacturing environment. Key points include the need for cleanable facilities, trained staff, validated processes, thorough testing, and effective complaint management. Compliance with these standards ensures product quality and safety.

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Vijay Kumar
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16 views2 pages

GMP Requiments

The document outlines essential requirements for facility design, personnel training, documentation, production control, quality control, materials management, validation, complaint handling, and self-inspection in a manufacturing environment. Key points include the need for cleanable facilities, trained staff, validated processes, thorough testing, and effective complaint management. Compliance with these standards ensures product quality and safety.

Uploaded by

Vijay Kumar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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1.

Facility and Equipment

 Design & Construction: Must be suitable for the type of manufacturing with cleanable
surfaces, proper ventilation, and separation to avoid cross-contamination.
 Maintenance: Regularly maintained to prevent failures.
 Utilities: Properly designed systems for water (WFI, purified), HVAC, compressed air,
and steam.
 Validation: Equipment and systems must be qualified (IQ/OQ/PQ).

2. Personnel

 Training: Staff must be trained in GMP and job-specific procedures.


 Hygiene: Personal hygiene standards must be enforced (e.g., gowning, no jewelry, clean
hands).
 Responsibilities: Clear roles, with Quality Assurance (QA) overseeing compliance.

3. Documentation

 SOPs: Standard Operating Procedures for all operations.


 Batch Records: Detailed records for every batch, including raw materials, processes, in-
process checks, and final testing.
 Traceability: Ability to trace every component and action.
 Data Integrity: ALCOA principles (Attributable, Legible, Contemporaneous, Original,
Accurate).

4. Production and Process Control

 Validated Processes: Manufacturing processes must be validated and shown to be


reproducible.
 In-Process Controls: Regular checks during production (e.g., weight variation, pH,
temperature).
 Change Control: Any changes to materials, process, or equipment must be documented
and assessed.
5. Quality Control (QC)

 Testing: All raw materials, in-process samples, and finished products must be tested.
 Stability Testing: Ensures product maintains quality over shelf life.
 Out-of-Spec (OOS): Procedures for investigating and addressing OOS results.

6. Materials Management

 Receipt & Storage: Materials must be checked, labeled, and stored appropriately.
 Quarantine Area: Materials should be held until approved for use.
 Inventory Control: Must prevent mix-ups and allow traceability.

7. Validation and Qualification

 Validation Master Plan (VMP): Document detailing the approach to validation.


 Equipment Qualification: IQ (Installation), OQ (Operational), PQ (Performance).
 Cleaning Validation: Ensures removal of residues to acceptable levels.
 Process Validation: Confirms processes consistently produce quality products.

8. Complaints, Recalls, and Product Returns

 Complaint Handling: Investigated promptly and thoroughly.


 Recall Procedure: Must be in place to remove defective products.
 Returned Goods: Assessed for quality before reuse or disposal.

9. Self-Inspection and Audits

 Internal Audits: Regular inspections to ensure compliance.


 CAPA System: Corrective and Preventive Actions for any identified issues.

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