Tag: Saxony

SCHEDULE G – (THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945 )

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SCHEDULE G – (THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945 ) Aminopterin L-Asparaginase Bleomycin Busulphan; its salts Carbutamide Chlorambucil;its salts Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine Chlorpropamide; its salts Chlorthalidone and other derivatives of Chlorobenzene compound. Cis-Platin Cyclophosphamide; its salts Cytarabine Daunorubicin Di-Isopropyl Eluorophosphate Disodium Stilboestrol Diphosphate Doxorubicin Hydrochloride Ethacrynic…

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Uncategorized

SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

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Personnel Qualification for Aseptic Processing and Sterility Testing Area Objective: To lay down the procedure for Personnel Qualification to enter and work in the Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area Procedure: For the Aseptic Processing Area The…

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Microbiology

SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

Posted on By Pharmaceutical Guidanace

Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control Head…

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Microbiology

SOP on Viable Particle Monitoring of Drain Points– Sterile Product Manufacturing Facility

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Objective: To lay down the procedure for Viable Particulate Monitoring of Drain Points – Sterile Product Manufacturing Facility Scope: This SOP is applicable for Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability: Head – Quality Control / Nominee….

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Microbiology

SOP on calibration of pH meter

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Objective: To lay down a procedure for calibration of pH Meter. Scope: This SOP is applicable for calibration of pH Meter in quality control laboratory. Responsibility: Officer or above of QC laboratory is responsible for calibration of pH Meter Head Quality / nominee of QC department is responsible for reviewing and approval of the SOP…

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Quality Control

Aceclofenac 100 mg Film-coated Tablets

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Aceclofenac 100 mg Film-coated Tablets 1. Name of the medicinal product Aceclofenac 100 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 100 mg of aceclofenac For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White, round, biconvex film-coated tablets, 8 mm diameter. 4. Clinical particulars 4.1…

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Production

Q7 GMP Guidance for Active Pharmaceutical Ingredients

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 Guidance for Industry II. QUESTIONS AND ANSWERS A. Scope (1) 1.1: Should GMP according to ICH Q7 be applied for manufacturing steps before the defined API starting material, i.e., steps not identified in grey in Table 1? ICH Q7 does not apply to steps prior to the introduction of the API starting material.  However, there…

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Audit and Guideline

Sampling and testing of Sterile surgical Gloves

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Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring the compliance to the procedure. Head–Microbiology shall…

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Microbiology

STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2)

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STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2) Drug Product General Photostability Testing Selection of Batches Container Closure System Specification Testing Frequency Storage Conditions Stability Commitment Evaluation Statements/Labeling Drug Product General The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance…

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Audit and Guideline

STABILITY TESTING OF NEW DRUG SUBSTANCES Q1A(R2)

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STABILITY TESTING OF NEW DRUG SUBSTANCES  Q1A(R2) COVER NOTE FOR REVISION OF Q1A(R) The changes made in Q1A(R) that result from adoption of ICH Q1F “Stability Data Package for Registration Applications in Climatic Zones III and IV”. These changes are: The intermediate storage condition has been changed from 30°C ± 2°C/60% RH ± 5% RH…

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Audit and Guideline

Pharmaceutical Development as per USFDA

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PHARMACEUTICAL DEVELOPMENT I. INTRODUCTION II. PHARMACEUTICAL DEVELOPMENT A. Components of the Drug Product 1. Drug Substance 2. Excipients B. Drug Product 1. Formulation Development 2. Overages 3. Physicochemical and Biological Properties C. Manufacturing Process Development D. Container Closure System E. Microbiological Attributes F. Compatibility III. GLOSSARY   INTRODUCTION The Pharmaceutical Development  provides an opportunity to…

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Audit and Guideline, Production

INPROCESS CONTROL OF CAPSULE MANUFACTURING

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INPROCESS CONTROL OF CAPSULE MANUFACTURING OBJECTIVE: To lay down the procedure for In process Control of Capsule Manufacturing. SCOPE: This SOP covers the responsibility and procedure for In process control during capsule manufacturing. RESPONSIBILITY: In process Quality Assurance Executive/Officer. ACCOUNTABILITY: Quality Assurance Manager. PROCEDURE: Carry out line clearance at each stage of operation prior to…

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Production

PROCEDURE FOR CALIBRATION OF REFRIGERATOR

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OBJECTIVE:To describe the calibration procedure for distribution of temperature within the chamber of Refrigerator. SCOPE: his SOP shall be applicable for Calibration of Refrigerator at Pharmaceutical Industries. RESPONSIBILITY :             Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control PROCEDURE : Operate the refrigerator as per Standard Procedure. Insert the probe of…

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Quality Control

ANDA Submissions — Content and CTD Format (USFDA)

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ANDA Submissions — Content and CTD Format (USFDA) TABLE OF CONTENTS  CTD FORMAT  A. Module 1 – Administrative Information  Forms and Cover Letter Administrative Information References Other Correspondence Labeling B.Module 2 – CTD Summaries Quality Overall Summary Clinical Summary C.Module 3 – Quality Drug Substance Drug Product Appendices Regional Information Literature References D.Module 4 –…

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Audit and Guideline