Preparing for FDA & EU GMP Compliance
- Input to Facility design
- Documentation
- R&D documentation
- Support for regulatory affairs activities
- GAP analysis
Setting QA & QC System
- Documentation
- Specification, method of analysis, Standard operating procedure, Protocols, policies, companies guidelines etc. preparation & review
- Analytical method development and validations
- Internal review / audit / Data integrity
- Sampling, Statistical Trend, Stability and other laboratory system implementation & review.
CTD/ Dossier Services
- Expertise in Preparing, Reviewing and Assessing the dossier of Pharmaceutical product which includes:
- Module 1 (Administrative and prescribing information that may be region specific)
- Module 2 (Summary of the Pharmaceutical Product)
- Module 3 (Includes overall detailed Quality summary of the Pharmaceutical Product)
- Preparation and Registration of Dossiers for different countries
DMF's Preparation, Registration and Filing
- We assist in Scientific Writing of Drug master files for the Active Pharmaceutical Ingredients (API).
- We provide different types of DMF with latest updating and country specific format.
Training
- Pharmaceutical understanding for Non-Pharma team members
- Worldwide Regulatory authorities and their functions
- Schedule M
- Schedule Y (Clinical)
- 21 CFR Parts 210 and 211
- 21 CFR part 11
- European Pharmaceutical cGMP
- Q7A (For API manufacturer)
- On Job training (For QC Laboratory- In house at our Associates premises)
- Training to Departmental heads to certify as internal trainer
- Data integrity
- Specialize training for QC, QA & Manufacturing
- Master Batch Records / Batch records
- QbD
- Validation Master Plan
- Validations & Qualification
- Documentation system
- Site Master File
- Specific GMP related topics / Guidelines
- (e.g. HVAC, water system qualification, OOS, SOP preparation, regulatory requirements while Specification designing, Analytical method Validation, procedure validation etc)
- 100+ topic on Quality Functions
Validation and Qualification
- Preparation of Validation Master Plan
- Analytical Procedures
- (Assay, Impurities, Organic Volatile impurities etc. for Finished pharmaceutical products, API & its intermediates)
- Process
- (for Finished pharmaceutical products, Active Pharmaceutical Ingredients & intermediates – Non Sterile & Sterile)
- Cleaning validation
- Analytical Equipment
- Process Equipment related to Finished pharmaceutical products, Active Pharmaceutical Ingredients
- related start from User requirement specification (URS), Design qualification (DQ), Factory acceptance
- test (FAT), Site acceptance tests (SAT), Installation qualification (IQ), Operation Qualification (OQ) &
- Performance Qualification (PQ) & re-qualification.
- Supporting – Utilities, HVAC, Water etc.
Audit and GAP analysis
- GAP analysis / Due Diligence for Pharmaceutical companies in terms of GMP strength
- & Product portfolio
- Internal review / audit
- Mock audit
- Periodic review for systems, follow-up audits
- Third party audit (On behalf of overseas end users; audit in India and China for Raw material suppliers
- for Finished product, API, Excipients, Packaging & Pharmaceutical intermediates)
Out Sourcing of API, GMP compliance & Vendor evaluation
- Auditing supplier System compliance (Vendor approval support)
- Auditing Contract testing Laboratory for Method development & Validation
- Periodic review for systems, follow-up audits
- Helping for meeting regulatory requirement
Other regulatory support
- R&D stage GMP support & documentation –Product development report, Technology transfer
- documentation etc
- Assistance to regulatory filing
- Assisting for preparation of response to regulatory agencies or customer’s audit non-compliance report
Laboratory Support
- Test reference material – Impurities/degradation products – those are not available with official
- sources, Pharmacopoeia and commercially*
- Working reference material - Impurities/ degradation products – those are available with
- Pharmacopoeia – but at very high cost*
- Following activities to support:-
- Analytical Studies/ specific testing
- Analytical Method development and Validation,
- Stability studies as per Different Zones for the active ingredients as well as pharmaceutical products