Last Updated on September 20, 2023 by The Health Master
Guidance documents: Everything you need at one place
It is important for the industry (pharmaceuticals, homoeopathy, cosmetics, medical devices, testing laboratories, drug developers, clinical trials, etc.) to stay up-to-date on the latest updates and information to ensure compliance with regulatory requirements and to bring safe and effective products to market by means of reading Guidance documents.
We have provided some guidance articles / documents for the industry that provide information, clarification, etc., on the interpretation and application of regulatory requirements for the development, manufacture, and marketing of products.
These articles / documents serve as a valuable resource for the industry and regulatory agencies, to ensure the quality, safety, and efficacy of products.
Click the below links to read relevant articles:
Guidance documents for industry
Guidance articles for industry
Quality Assurance Vs Quality Control in the Pharma Industry
NABL certification for Laboratories: LetтАЩs understand
Major FDA audit findings about Equipment and Instruments
Equipment and Instruments: Maintenance, difference and importance in the Pharma Industry
Quality Assurance in the Pharmaceutical Industry
NIPER: A Comprehensive Guide to NIPER Institutes in India
Latest on Indian Pharmacopoeia Commission (IPC)
Types of inspections done by USFDA: Read in detail
AHUs, Air Types, Air Changes and their Functions in Pharma Industry
Understanding Airlock Systems in Pharma Industry
Upcoming events: Pharma, Cosmetics, Homoeopathy & Medical Devices
Cosmetics Testing in India: A Comprehensive Guide
Airlocks in the Pharma Industry: An essential component
Line clearance and maintenance in manufacturing: A comprehensive guide
Difference between Validation and Calibration in the Pharma Industry
The Effectiveness of 70% Alcohol as a Disinfectant
Wet Granulation vs Dry Granulation: Understanding the Key Differences
Understanding GMP, cGMP, and WHO-GMP
USFDA issues Form 483 to Pharma Companies: LetтАЩs know all about it
Calibration of Laboratory Instruments
Difference: Disintegration and Dissolution test in pharma industry
How to prepare SOPs in the Pharma Industry
Difference between branded and generic medicines
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Duties and responsibilities of QA person in Pharma Industry
Types of Tablet Coating and its Functionality in pharma industry
Dissolution test: Importance in Pharma Industry
Lux level in Industry (Pharma, Cosmetics, Homeopathy & Medical Devices)
NSQ Drug: Route cause analysis and CAPA
Area required for manufacturing of Drugs, Cosmetics, Homoeopathic & Blood Centre
Procedure of manufacturing license
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Commercial Testing Laboratories
Forms
Schedules
Area required
Area required for manufacturing of Drugs, Cosmetics, Homoeopathic & Blood Centre
Testing laboratory
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Commercial Testing Laboratories
Latest Notifications: Testing Laboratories
Commercial Testing Laboratories
Commercial Testing Laboratories: Procedure
Updated list of Medical Device Testing Laboratories (MDTLs)
List of Laboratory Instruments for Pharma & Cosmetics Industry
NABL: List of NABL Accredited Testing Laboratories
NABL 164 released : Guidelines for Inter-laboratory comparison
NABL releases NABL 136: specific criteria for X-Ray equipment
NABL 126: Specific criteria for calibration of Medical Devices
Latest Notifications
Latest Notifications: D&C Act 1940
Latest Notifications: D&C Rules 1945
Latest Notifications: Cosmetics
Latest Notifications: Medical Devices
Latest Notifications: Homoeopathic
Latest Notifications: Blood Centre / Bank
Latest notifications тАУ DPCO / NPPA
Latest Notifications: EC Act (Essential Commodities Act)
Latest Notifications: DMROA (Drugs and Magic Remedies Act)
Latest Notifications: Testing Laboratories
Latest Notifications: New Drugs and Clinical Trials
Latest Notifications: COTPA (Cigarettes and Tobacco products)
NPPA / DPCO
Latest on National Pharmaceutical Pricing Authority (NPPA)
Latest notifications тАУ DPCO / NPPA
NPPA updated price lists: Download
Latest Notifications: EC Act (Essential Commodities Act)
FAQs тАУ On DPCO: Drugs (Prices Control) Order, 2013
Alerts
Circulars on Pharmaceuticals
FAQs
FAQs тАУ on Schedule-P (Expiry Date of drugs)
FAQs тАУ on Blood Bags and its Testing
FAQs тАУ On DPCO: Drugs (Prices Control) Order, 2013
FAQs тАУ on Blood Pressure Monitoring Devices
FAQs тАУ on Notification: Marketer of drugs
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
FAQs тАУ on Drug Permission in Brand or Generic Name
FAQs on Sanitizer, N95 Mask & Digital Thermometer
FAQs тАУ on Blood Bank / Centre (Series-3)
FAQs тАУ on Blood Bank / Cantre (Series-2)
FAQs тАУ on Blood Bank / Centre (Series-1)
FAQs тАУ on Disinfectants (Series-2)
FAQs тАУ on Disinfectants (Series-1)
FAQs on Medical Devices Rules, 2017
FAQs about New Drug, Banned drugs etc.
FAQs тАУ On тАШGood NightтАЩ, тАШAll OutтАЩ, тАШHitтАЩ and тАШHarpicтАЩ etc.
FAQs тАУ on Ranitidine tablets and injections in India
FAQs тАУ On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) dated 06-11-2019) etc.
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