CDSCO - Guidance for Industry

4.8.3 Certificate of analysis (Pilot scale batches) 4.9. Reference standards 4.10. Container closure system 4.10.1 Packaging Materials: Specifications and Test methods 4.10.2 Art work – Packaging material (label, primary carton, secondary carton and Pack Insert. 4.10.3 Packaging Specifications 4.11 Stability data

Fullscreen Download

Tags:

Certificate, Secondary

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Other abuse

Transcription of CDSCO - Guidance for Industry

Documents from same domain

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION …

cdsco.gov.in

1. Application in Form-44 duly signed, by the Authorized signatory with details of name and designation along with relevant drugs details and utilization. 2. Treasury Challan (TR–6)/Bharatkosh receipt of Rs. 25000/- (Medical and Public Health Account: 0210). 3. Application in Form-12 duly signed, by the Authorized signatory with details

Applications

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

cdsco.gov.in

Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC). Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.

Reporting, Monitoring, Adverse

LIST OF LICENSED HUMAN VACCINE MANUFACTURING …

cdsco.gov.in

8 Green signal BioPharma Ltd, 49, Pappankuppan Village, Gummidipoondi, Chennai–601201 BCG Vaccine TN00002462 in Form 28D 12.05.2016 to 11.05.2021 9 a. Panacea,

GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR …

cdsco.gov.in

The defective products related to quality includes Not of Standard Quality, Adulterated or Spurious drugs. Safety and efficacy related recalls include serious adverse reactions and death. Recalls also include drugs prohibited under the Provisions of Drugs & Cosmetics Act and also those products for which product licenses are suspended/cancelled.

Guidelines, System, Quality, Safety, Alert, Recall, Cosmetic, Rapid, Efficacy, Guidelines on recall and rapid alert system for

1. APPLICATIONS FOR INVESTIGATIONAL NEW DRUGS …

cdsco.gov.in

2 Name of the applicant 3 Name of the New Drug a. Composition of the New Drug b. Dosage Form c. Proposed indication for the New Drug 4 Application in Form 44 complete in all respect duly signed and stamped by authorized person of the firm 5 Treasury Challan of INR 50,000 (for Phase I) or INR 25,000 (for Phase II / III)

Applications, Drug, Investigational, Investigational new drug applications for, New drugs

KM 554e-20180422102116 - CDSCO

cdsco.gov.in

(vi) "Hazard" potential source of harm (vii) "Lay person" means an individual that does not have formal training in a relevant field or discipline. (viii)"Risk" means combination of the probability of occurrence of harm and the severity of that harm. (ix) Words and expressions used but not defined in these guidelines shall have the

Potential

National List of Essential Medicines (NLEM) 2015 - CDSCO

cdsco.gov.in

National List of Essential Medicines (NLEM) 2015 Page 6 of 38 The Core-Committee through a series of meetings and consultations across the country, deliberated and revised the National List of Essential Medicines