Actos tablets 1. Name of the medicinal product Actos 15 mg tablets Actos 30 mg tablets Actos 45 mg tablets 2. Qualitative and quantitative composition Actos 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). Excipient with known effect Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4). Actos 30…
ABILIFY 1 mg/mL oral solution 1. Name of the medicinal product ABILIFY 1 mg/mL oral solution 2. Qualitative and quantitative composition Each mL oral solution contains 1 mg of aripiprazole. Excipients with known effect (per mL) 200 mg fructose, 400 mg sucrose, 1.8 mg methyl parahydroxybenzoate (E218), 0.2 mg propyl parahydroxybenzoate (E 216) For the…
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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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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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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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…
Investigating Out-of-Specification IDENTIFYING AND ASSESSING OOS TEST RESULTS — PHASE I: LABORATORY INVESTIGATION PHASE II: FULL-SCALE OOS INVESTIGATION
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…
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…
USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS
