Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Forms: For Homoeopathy Medicines - December 22, 2024
- Key Notes on Revised Schedule M: Point No. 12 – Premises - December 22, 2024
- Key Notes on Revised Schedule M: Point No. 11 – Personnel - December 21, 2024
Last Updated on December 7, 2024 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 documents / articles 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 and 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
Key Notes on Revised Schedule M: Must read
Key Changes for Homoeopathic Medicines: GSR 669(E) dated 28-10-2024
Significance of Granules Manufacturing in the Pharmaceutical Industry
Gist of the draft notification: Compounding of Offences under the Drugs and Cosmetics Act
NABL certification for Laboratories: Let’s understand
Major FDA audit findings about Equipment and Instruments
Guidance documents for industry
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
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
Procedure to obtain license for Blood Centre (Blood Bank)
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 – 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 – DPCO / NPPA
NPPA updated price lists: Download
Latest Notifications: EC Act (Essential Commodities Act)
FAQs – On DPCO: Drugs (Prices Control) Order, 2013
Alerts
Circulars on Pharmaceuticals
FAQs
FAQs – on Schedule-P (Expiry Date of drugs)
FAQs – on Blood Bags and its Testing
FAQs – On DPCO: Drugs (Prices Control) Order, 2013
FAQs – on Blood Pressure Monitoring Devices
FAQs – on Notification: Marketer of drugs
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
FAQs – on Drug Permission in Brand or Generic Name
FAQs on Sanitizer, N95 Mask & Digital Thermometer
FAQs – on Blood Bank / Centre (Series-3)
FAQs – on Blood Bank / Cantre (Series-2)
FAQs – on Blood Bank / Centre (Series-1)
FAQs – on Disinfectants (Series-2)
FAQs – on Disinfectants (Series-1)
FAQs on Medical Devices Rules, 2017
FAQs about New Drug, Banned drugs etc.
FAQs – On ‘Good Night’, ‘All Out’, ‘Hit’ and ‘Harpic’ etc.
FAQs – on Ranitidine tablets and injections in India
FAQs – On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) dated 06-11-2019) etc.
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Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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