(Medical Devices Division) - Central Drugs …

GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR IMPORT LICENSE OF NOTIFIED MEDICAL DEVICES. Page | 1 Guidance Document (Medical Devices Division)

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Annexure-1 GMP CHECKLIST

SOP No.: EP-INS-004 Page 1 Annexure-1 GMP CHECKLIST (Based on WHO Good Manufacturing Practices (GMP) for active pharmaceutical ingredients stated as per

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INVESTIGATIONAL MEDICINAL PRODUCT …

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LIST OF NEW DRUGS APPROVED IN INDIA FROM …

LIST OF NEW DRUGS APPROVED IN INDIA FROM 1991 TO 2000 S. No Name of Drug Pharmacological action/ Indication Date of Approval 1 Ciprofloxacin 0.3% w/v Eye

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List of NABL Accredited Laboratories in India

Sr. No. Name of the Laboratory Nature of Lab Field Discipline Group Address Contact Details Organization Type 1 Alcatec Research Laboratories India Pvt.

(Medical Devices and Diagnostic Division)

Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

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Manufacturing and Marketing permission issued …

S.No. Drug Name Indication Date of Approval 10 Everolimus tablets 2.5mg. 5mg and 10mg “Treatments of adults patients with progressive, well differentiated, non- ...

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LIST OF LICENSED BLOOD BANKS IN INDIA * …

LIST OF LICENSED BLOOD BANKS IN INDIA * (February, 2015) Sr. No. State Total No. of Blood Banks 1. Andaman and Nicobar Islands 03 2. Andhra Pradesh 140 3.

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SUMMARY OF PRODUCT CHARACTERISTICS

Summary of Product Characteristics lactating women may be considered after careful evaluation of the benefits and risks in case of a medical emergency or an epidemic.

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GUIDELINES ON RECALL AND RAPID ALERT SYSTEM …

Page 3 of 13 5.0 Recall Classification: Recall classification is a numerical designation, I, II, or III, that is assigned to a particular product recall that indicates the relative degree of health hazard by country

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OHSAS 18001:2007 Overview - Perry Johnson …

• ISO 9001 • ISO 14001 • AS 9100, 9110 & 9120 • ISO/TS 16949 • Responsible Recycling-R2 • RIOS • ISO 13485 • SQF • TL 9000

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Medical Device Quality Agreement Template - …

Medical Device Quality Agreement Template Page 6 of 17 Prepared by Ombu Enterprises, LLC www.OmbuEnterprises.com ISO 13485:2003 Medical devices – Quality management systems – Requirements for

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ISO 14001:2015 ExtErnal ISSuES - Perry Johnson …

• ISO 9001 • ISO 14001 • AS 9100, 9110 & 9120 • ISO/TS 16949 • Responsible Recycling-R2 • RIOS • ISO 13485 • SQF • TL 9000 • OHSAS 18001

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List of Quality System Standards - 9000 Advisers

List of Quality System Standards ISO 9000, ISO 9001 and ISO 9004 The ISO 9000 family of standards has been developed to assist organizations of all types

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Supplier Quality Requirements for Purchased …

Supplier Quality Requirements for Purchased Materials or Service QAR-0001-C Rev. P Please verify Revision Before Use. Page 1 of 8