Western Isles

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. … Read more

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 … Read more

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 … Read more

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 … Read more

Actelsar HCT tablets

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Actelsar HCT tablets 1. Name of the medicinal product Actelsar HCT 40 mg/12.5 mg tablets Actelsar HCT 80 mg/12.5 mg tablets 2. Qualitative and quantitative composition Actelsar HCT 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Actelsar HCT 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and … Read more

Actos tablets

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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 … Read more

ABILIFY 1 mg/mL oral solution

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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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

Deviation Handling and Quality Risk Management

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Cleaning Validation as per APIC Guideline

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PPT on prevent the spread of COVID 19 infection at the workplace

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Investigating Out-of-Specification

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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

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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 … Read more

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 … Read more

USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS

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USFDA GUIDELINE FOR DRUG QUALITY SAMPLING AND TESTING (DQST)- HUMAN DRUGS  

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 – … Read more

List of Documents required for Pharma Quality Control Departments (GMP & GLP Compliances)

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