what are the parametrs that control the QC Inspection by the QA deapartments . what is the observation need to improve our quality control labs.
I would suggest first QA should conduct assessment audit of QC laboratory in totality considering all the aspects of Good Laboratory Practices (GLPs). This will identify weaknesses in the QC Lab systems. Address the weaknesses or non-conformances or the areas which need improvements and need to be strenghtened. Prepare CAPA plans and execute. After implementation of CAPA conduct follow up internal audits to assess improvement in compliance level.
These are some of the GLP aspects which need to assessed through internal audits:-
- Premises (Facilities)
- Quality Management System (Laboratory Manual, Policies & SOPs, Work instructions)
- Laboratory safety
- Personnel (Qualification, Experience, Training, Adequacy of numbers)
- QC equipment, Instruments (Availability, Calibration, Qualification & Validation)
- Volumetric soultions, Lab reagents, Chemicals, Buffers & indicators standardisation & management
- Volumetric glass apparatus management (Procurement, Calibration & storage)
- Microbiological cultures management (Procurement, Maintainance & storage etc.)
- Culture media management
- Reference standards & Working standards (Primary & Secondary) management
- Specifications and test procedures (Raw materials, Packaging components, Intermediates, Final products)
- Analytical records, QC related documentaton
- Archives (QC Documents storage system)
- Retention samples (Control samples) management
- Control of Raw materials, Packaging components, Intermediates, Finished products
- Sampling management (RM, PM, In-process, Finished products) and analysis
- Documents and data control, Data integrity aspects, Electronic records compliance to 21 CFR part 11 or Eudralex volume-4 Annex 11 or equivalent requirements
- Stability samples analysis and management
- Maintainance, Husekeeping
- Handling deviations, Non-conformances, OOS Laboratory results and investigations
- Contract laboratories management (External vendors / service providers)
Based on these elements, exhaustive checklists should be generated for every aspect / section as areference guidelines for conducting QC laboraotry assessment.
Please consider following points for conducting internal audits (Self inspection) of the production areas,
Detailed audit checklists should be prepared for reference based on these points. Additionally, product type specific (Tablets, Capsules, Oral liquids, Creams, Ointments, Powders, Sterile products- SVP, LVP, Lyophilyzed injections) checklists also can be prepared and followed.
- Basic manufacturing requirements (Premises & Production Facilities)
- Design & construction
- Installation & location of mfg equipment
- Qualification of manufacturing equipment & calibration of measuring devices
- Process validation
- Cleaning validation
- Computerized systems and electronic data handling (21 CFR part 11, Eudralex volume-4 Annex-11 or equivalent compliance)
- Batch & Lot numbering system
- Measures taken to prevent contamination & cross contamination (Technical & Administrative measures)
- Weighing & dispensing of materials
- Mixing & Granulation, Drying, Blending & lubrication
- Compression & Metal detection system (Tablets)
- Blend preparation (capsules)
- Capsules filling, polishing, Metal detection
- Quarantine, In-process material storage
- Preventive & Breakdown maintenance
- Qualification, Validation of utilities (HVAC, Purified water, Compressed air, Nitrogen, Vacuum etc.)
- BMRs (Batch Manufacturing & Packing records)
- Equipment usage logbooks
- Documentation in Production
- SOPs, Work Instructions, Forms etc.
- Process controls
- Training, Job Responsibilities (production staff)
- Facility Housekeeping & cleaning, Disinfection etc.
- Environmental Monitoring (Temp., Air pressure differentials, Relative Humidity, Viable & non-viable count in classified areas etc.)
- Material & Men movement in production
- Safety measures
(Warehousing of RM, PM, Finished Products related activities are not included)
For API manufacturing unit a separate checklist should be peprepared based on ICH-Q7 or Shedule-M GMP requirements.