sop-of-Revalidation/Requalification of HVAC system

 sop-of-Revalidation/Requalification of HVAC system objective Scope Responsibility Qualification team Abbreviation and definition Pre-requisites Precautions and instruction (Health, Safety, and Environment) Air velocity, the Air volume, and air Change Per hour measurement Procedure for HEPA Filter integrity Procedure for non-viable particle count Procedure for viable particle count Recovery Study Airflow Visualization Procedure for Temperature, Relative Humidity, … Read more

OUT OF SPECIFICATIONS (OOS)

OUT OF SPECIFICATIONS (OOS) Out of Specification (OOS) means the test result that falls outside the specifications or acceptance criteria which has been specified in the official compendia monographs or the finished product specification in registration dossiers. OOS IS OBSERVED IN THE ANALYSIS OF: Stability study Finished product In-process Raw materials Packing materials Identification of … Read more

Tablet Defects and Remedial action in Pharma

Tablet Defects and Remedial action in Pharma In the routine manufacture of tablets, various defects are observed. The source of the problem or the defect is the formulation, the compression or coating equipment, or a combination of these. Tablet defects are deficiencies that are usually encountered in tablet formulation. Depending on experience, machinery, and excipient … Read more

USFDA 483 Observations – Top 5 Common Observations

USFDA 483 Observations – Top 5 Common Observations Quality control procedures not in writing fully followed Scientifically sound laboratory controls not established Investigations of discrepancies, failures to adequately review Absence of Written Procedures for production and process controls Written procedures not established/followed for cleaning and maintenance equipment Lack of or inadequate procedures (CAPAs) Lack of … Read more

SOP for Quality Assurance Policy

 SOP for Quality Assurance Policy Quality assurance policies are to ensure that routine and continuous quality improvement is an essential, and fundamental part of our organization. Controlling change will aim for continuous improvement in the quality of all aspects of its work as part of its determination to help to get achieve the highest possible … Read more

RISK MANAGEMENT METHODOLOGY – ICH Q9

RISK MANAGEMENT METHODOLOGY – ICH Q9 Quality risk management (QRM) – a scientific and practical approach to decision-making. QRM provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity, and detectability of the risk. Quality risk management (QRM) In general, risks … Read more

TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9

TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9 TABLE OF CONTENTS 1. INTRODUCTION…………………………………………………………………………………………………1 2. SCOPE………………………………………………………………………………………………………………..2 3. PRINCIPLES OF QUALITY RISK MANAGEMENT…………………………………………………2 4. GENERAL QUALITY RISK MANAGEMENT PROCESS…………………………………………..2 4.1 Responsibilities ………………………………………………………………………………………………… 3 4.2 Initiating a Quality Risk Management Process ……………………………………………………. 3 4.3 Risk Assessment……………………………………………………………………………………………….. 3 4.4 Risk Control……………………………………………………………………………………………………… 4 4.5 Risk Communication…………………………………………………………………………………………. 5 4.6 Risk … Read more

DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE

SECTIONS OF THE DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE ARRANGEMENT OF SECTIONS CHAPTER I INTRODUCTORY SECTIONS 1. Short title, extent and commencement. 2. Application of other laws is not barred. 3. Definitions. 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and … Read more

REQUIREMENTS OF PHARMACEUTICAL MANUFACTURING PLANT AND EQUIPMENT

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BASIC REQUIREMENTS OF PHARMACEUTICAL MANUFACTURING PLANT AND EQUIPMENT 1. External Preparations. – The following equipment’s are recommended for the manufacture of External preparations i.e. Ointments, Emulsion, Lotions, Solutions, Pastes, Creams, Dusting powders and such identical products used for external applications whichever is applicable, namely :- (1) Mixing and storage tanks preferably of stainless steel or … Read more

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