Analytical Method Development
Analytical Method Validation
Validated analytical method only can give accurate results. Validation of analytical method is must for pharmaceutical analytical laboratory.
There is guideline for analytical method validation from ICH & US FDA.
ICH-Q2(R1)- Validation of Analytical Procedures - Text and Methodology
US FDA draft guidance on analytical procedures & method validation
EDQM guideline
EDQM-Validation of analytical procedure
Analytical Method Transfer
There is no definite guidance from USFDA on this subject. Recently USP has come up with a stimuli article on this subject. For more information refer the link below.
Transfer of analytical procedures-A new general information chapter
Instrument calibration
1. Disolution Apparatus 1 & 2 - Mechanical calibration
2. Prednisone tablet for PVT - New lot - P1I303
Instrument Qualification
Annex 1: Qualification of HPLC Equipment
Annex 2: Qualification of GC Equipment
Annex 3: Qualification of UV-Visible Spectrophotometers
Annex 4: Qualification of IR Spectrophotometers
Result & Reports
Out-Of-Specification (OOS)
Investigation is must for any product failures to find out the root cause and Corrective And Preventive Action(CAPA). USFDA come up with definite guidance on this subject. This guideline helps to handle OOS data and procedure for investigation. For more information refer the below link.
Out-Of-Trend(OOT) Analytical Results
An analytical result which fall in with in the specification limit but does not follow with in the trend or unexpected result. Normally any analytical result which fall in Out-Of-Specification requires a detailed investigation to find a root cause failure and folowed by a currettive And Preventive Action(CAPA).
Though regulation demands investigation to be completed with in thirty days but most of the cases industries fails to complete the invsetigation with in stipulated period to find root cause.Meanwhile its end up with few more failures. To avoid such things happen the current practice starts investigation when results appear to be ou-of-trend.
The following links help to know more about OOT
Auditing pharmaceuticals quality control Laboratory
Auditing quality control laboratory is must for continuous improvement and regualotory requirements. It helps to keep QC laboratory in high compliance level and maintain best practices through continuos improvement by training and gap analysis.
There is a guideline from US FDA for inspection pharmaceuticals QC laboratory it
includes chemical lab and Micro lab.
Pharmaceutical Quality Control Labs
Audit check list for Pharmaceutical Quality Control Labs by PICScheme Microbiological Pharmaceutical Quality Control Labs Guidance document on part 11-Electronic signature & Electronic record NEW: Annex 1: Validation of computerised calculation systems: example of validation of in-house software - Spread sheet/Microsoft Excel NEW: Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) NEW: Annex 3: Validation of computers as part of test equipment GAMP 4 to GAMP 5 -Summary
Elemental Impurities—Comments and Responses  (1.1MB) Flow Microscopy—Dynamic Image Analysis for Particle Counting (1.1MB) A Recombinant Factor C Procedure for the Detection of Gram-negative Bacterial Endotoxin (1.7MB) High level list of Australian and International pharmaceutical regulations and standards REGULATIONS
Australian
Australian Code of Good Manufacturing Practice for Medicinal Products – Therapeutics Goods Administration 16 August 2002. Australian Code of Good Manufacturing Practice for Veterinary Chemical Products – Australian Pesticides & Veterinary Medicines Authority. Australian Regulatory Guidelines for Complementary Medicines – Therapeutics Goods Administration June 2005. Australian Medical Device Guidelines – Therapeutics Goods Administration | International
United States
Code of Federal Regulations 21CFR 210 - cGMP in Manufacturing, Processing, Packing, or holding of Drugs; General – U.S. Food & Drug Administration Code of Federal Regulations 21CFR 211 cGMP for Finished Pharmaceuticals – U.S. Food & Drug Administration Code of Federal Regulations 21CFR 600 - Biologics – U.S. Food & Drug Administration Europe
Eudralex Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice – European Commission | Links to the Associations and Affiliations including general pharma, engineering, scientific and project management. General Pharmaceutical
- Pharmaceutical Inspection Cooperation Scheme (PIC/S)
www.picscheme.org - World Health Organisation (WHO)
www.who.int
- Parental Drug Association (PDA) Home Page – Intramuscular and Intravenous drug news and information.
www.pda.org
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – scientific and technical aspects of product registration.
www.ich.org
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Engineering
- International Society of Pharmaceutical Engineering (ISPE) Home Page – worlds largest non-profit professional organisation serving pharmaceutical and biotech manufacturing professionals.
www.ispe.org - Engineers Australia Home Page – Revised and updated Institution of Engineers Australia (IEAust) Home Page. General information and news for all aspects of engineering in Australia.
www.engineersaustralia.org.au
- Association of Professional Engineers, Scientists and Managers, Australia (APESMA) Home Page
www.apesma.asn.au
Scientific
- Biospectrum Asia Home Page – Informative website on the pharma/biotech industries in Asia.
www.biospectrumasia.com
- Australia’s Biotechnology Organisation (Ausbiotech) Home Page – Australia wide biotechnology information website.
www.ausbiotech.org - BioGeelong Home Page – News, links and information on the growing Geelong Biotechnology industry.
www.biogeelong.com.au
Project Management
- Project Management Institute (PMI) Home Page – Project Management resource website including standards, seminars, education programs and case studies.
www.pmi.org
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