Master Validation Program
Description
Validation has become an essential requirement for pharmaceuticals and chemicals. Both bulk drug and formulation facilities need validation and re-validations. FDA and ICH Norms have made validation studies mandatory.One needs thorough knowledge, implementation skills and training for the same.With this in view we have designed:
CD ROM ON MASTER VALIDATION PROGRAMME FOR PHARMACEUTICAL AND BULK DRUG MANUFACTURING (IN COMPLIANCE WITH US FDA, TGA, MCA, EUROPEAN UNION AND OTHER REGULATORY AUTHORITIES.)
It provides ready to use validation protocols, examples, and text for training and for actual validation.The protocols have been designed by experts in line.
Price :500.00 USD
2CheckOut.com Inc. (Ohio, USA) is an authorized retailer for goods and services provided by Perfect Consultants
Delivery Mode: Word Document ( You can edit the same to personalize with your own data)
Sample Pages
Testimonial
"The products (cGMP, Sops, Master Validation Program) we purchased from Perfect Consultants are an integral part of the action plan developed for this customer in order help them achieve compliance with the cGMPs - Dr Wade Edwards " .. Read More
Index for Master Validation Program
1.0 Validation of Manufacturing Facilities for Formulation
1.1 Validation of Facilities for Pharmaceutical Manufacturing.
1.2 Validation of Manufacturing Site
2.0 VALIDATION OF RAW MATERIALS
2.1 Checklist – Validation of Raw Materials Supplier.
3.0 VALIDATION OF UTILITIES
3.1 DQ- Validation of Steam Generating System.
3.2.1 DQ- Validation of Water System.
3.2.2 IQ- Validation of Water System
3.2.3 OQ- Validation of Water System
3.2.4 PQ- Validation of Water System.
3.2.5 Flow diagram for Water System.
3.2.6 SOP- Validation of Water System.
3.2.7 Design Qualifications for Water Systems
3.2.8 Process Qualification for Water Systems.
3.3.1 DQ- HVAC System.
3.3.2 IQ- HVAC System.
3.3.3 OQ, PQ - for HVAC System.
3.4.0 Validation of Electrical Services.
3.5.0 Validation of Vacuum System
4.0 VALIDATION OF MANUFACTURING PROCESS FOR DOSAGE FORMS
4.1 PQ- Capsules.
4.2 PQ- Liquid Oral.
4.3 PQ- Compressed Tablet.
4.4 PQ- Oral Suspensions.
4.5 PQ-Emulsion.
4.6 PQ-Powder for Reconstitution into Dry Syrup
4.7 PQ- Blending
4.8 PQ – Soft Gelatin Capsule.
4.9 Lyophilized Products.
4.10 PQ- Sterile Dry Powders
5.0 VALIDATION OF STERILE PRODUCTS
5.1 Aseptic Process Validation.
5.1.1 DQ – Steam Sterilizer.
5.1.2 OQ- Steam Sterilizer.
5.1.3 IQ – Steam Sterilizer.
5.4.1 IQ – Dry Heat Sterilizer.
5.4.2 OQ – Dry Heat Sterilizer.
5.4.3 PQ – Dry Heat Sterilizer.
5.5 Validation of Aseptic Filling.
5.6 Validation – Radiation Sterilization.
5.7 Method for Particulate Monitoring.
5.8 Acceptance Criteria for Particulate Count.
5.9 Example of Process Validation for Injectables.
5.10 PQ – Autoclave
5.11 PQ- Tunnel Sterilizer
6.0 VALIDATION OF COMPUTER SYSTEM
6.01 Checklist- Validation of Vendors for Computer Supply.
6.02 Validation of Computer System
6.03 Design Inputs for New Computer Systems.
6.04 DQ, IQ, OQ, PQ for Biometric System
6.05 DQ, OQ, PQ for Computer System
6.06 PQ- Data Migration
6.07 Validation for Computer System (FAQ)
6.08 Validation for LAN System
6.09 Validation During Software Development.
6.10 PQ for New Software
6.11 DQ – Computer System.
7.0 VALIDATION- FORMATS FOR MACHINES AND EQUIPMENTS
7.1 IQ, PQ, & OQ for Equipment’s.
7.2 Example IQ, PQ, & OQ for Instruments.
7.3 Guidelines, DQ – For Machines
8.0 VALIDATION OF ANALYTICAL SYSTEMS
8.1.1 IQ- HPLC
8.1.2 OQ- HPLC
8.1.3 PQ- HPLC
8.2 Validation of GC Instrument.
8.3 Analytical Validation of Residual Solvents.
8.4 Validation of Contract Analytical Lab
8.5 Validation of FTIR spectrometer
8.6 GLP
9.0 VALIDATION OF CLEANING
9.1 Cleaning Validation.
9.2 Cleaning Validation – Checklist
9.3 Validation of Cleaning Methods For Microbiological contamination.
9.4 Cleaning Validation by visually clean methodology
9.5 Cleaning validation of Liquid Filling Machines
9.6 Cleaning Validation for Dry Powder filling machine.
9.7 Validation of Ointment Tube cleaning process
9.8 Validation of Vial cleaning machine
9.9 Guidelines – Cleaning and Disinfection of Manufacturing Areas.
10.0 VALIDATION OF API MANUFACTURING
10.1 Validation of Manufacturing Facilities for API and Drug Intermediates.
10.2 PQ- API Manufacturing.
10.3 Cleaning Validation of API
10.4 Testing Methods for Water used for Final Purification of API
11.0 VALIDATION OF PROCESS FOR MEDICAL DEVICES
11.1 Process Validation for Medical Devices.(As per GHTF)
12.0 FDA Inspections
13.0 REGULATORY LINKS ON VALIDATION COMPLIANCE
13.01 EU & MCA Guidelines –1
13.02 EU & MCA Guidelines.
13.03 US FDA Guidelines.
13.04 US FDA Guidelines –2
13.05 US FDA Guidelines –3
13.06 WHO Guidelines
13.07 ICH Guidelines on Validation Methodology
13.08 ICH Guidelines for Validation of Analytical Methods.
13.09 Canadian Guidelines on Validation
13.10 PICS Guidelines.—1
13.11 PICS Guidelines –2
13.12 PICS Guidelines – 3
13.13 PICS Guidelines – 4
2CheckOut.com Inc. (Ohio, USA) is an authorized retailer for
goods and services provided by Perfect Consultants.