FDA – Warning Letter – 10 JUNE 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals 1. The company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch…
FDA 483 Warning Letter Dated JUNE 22, 2022 1. Each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)) and the company failed to prove this procedure. The company manufactured an OTC…
Unlocking Success with User Requirement Specification: Coating Machine URS In any project or system development, understanding and capturing user requirements accurately is crucial for success. User Requirement Specification (URS) is a structured document that serves as a foundation for defining and documenting user needs, expectations, and functional requirements. It forms a critical part of the…
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What are the different types of Quality Management systems (QMS)? Quality management is an essential system that every company should have in place. It is a set of practices that help companies identify, measure, and control the quality of their products. They help identify potential hazards before they become problems and can be used as…
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What is future mapping? “Future Mapping” is a remarkable new technology for problem-solving, creativity, and innovation. It involves a map with six areas to create an action scenario to achieve your goal … far more advanced than current methods … … reverses existing ideas on goal achievement … … turns thoughts into concrete action plans … Because…
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,…
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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…
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…
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…
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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…
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…
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…
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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…
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…
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SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA AS PER ICH Q6 A GUIDELINE Question – 1: The objective of the ICH Q6 A Guideline? Answer: ICH Q6 A Guideline is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products. Also assisting on the setting…
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Diphenhydramine HCL is Best cough medicine without dextromethorphan for treatment of sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms. Why Diphenhydramine HCL is used? Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes,…
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Validation Questions Question 1: When should a company validate/ revalidate cleaning procedures? When is validation not required? Answer: Ref. Section 7.0 and 10.0 Companies should look at each situation individually and determine the needfor validation. Section 7.0 provides a basic template, which may be used as a starting point in this evaluation. The necessity to…
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Cleaning process Control To verify and qualify a cleaning process, the cleaning process needs to be unremarkable and sufficiently robust for the to-be-cleaned equipment. It would be clear which way are considered part of the product process /unit operation and which are part of the cleaning process, for Illustration if the pre-rinse or wash-out which…
Functioning, cleaning and maintenance of Static Pass Box. Objective: To lay down the method for the ordinary operation, cleansing and preservation of the Static Pass Box (SPB). Scope: This SOP is relevant to the Static Pass Box present inside the microbiology lab. Responsibility: Chemist or above of QC laboratory. Head – Microbiology Section. Accountability: Head…
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