Tag Archives: Helsinki

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 …

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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 …

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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 …

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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 …

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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 …

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SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA

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. …

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Diphenhydramine HCL is Best cough medicine without dextromethorphan

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 …

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Validation Questions on cleaning validation (APICS)

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 …

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Cleaning process Control

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 …

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Operation, cleaning and maintenance of Static Pass Box.

 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 …

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Batch Manufacturing Record(BMR)

Batch Manufacturing Record(BMR) Product Name: Atorvastatin  calcium equivalent to Atorvastatin 10 mg,Batch Size:2000000 tablets Composition Each film-coated tablet contains: Atorvastatin  calcium equivalent to Atorvastatin 10 mg Checklist of BMR Check Points Batch release and composition Checklist of BMR General instruction Line clearance check for  dispensing Dispensing sheet of Raw Material …

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STERILITY ASSURANCE

STERILITY ASSURANCE 〈1211〉 INTRODUCTION Definition of sterility – An item is deemed sterile only when it contains no viable microorganisms. However, this textual definition cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing. Sterility cannot be demonstrated without the destructive testing of every sterile unit. …

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Functioning, cleaning and maintenance of Dynamic Pass Box

Functioning, cleansing and maintenance of Dynamic Pass Box Objective: To lay down the method for the habitual operation, cleansing and renovation of the Dynamic Pass Box (DPB). Scope: This SOP is relevant to the Dynamic Pass Box present inside the microbiology lab Responsibility: Chemist or above of QC laboratory. Head …

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Functioning, cleaning and maintenance of Sterile Garment Cabinet

Functioning, cleansing, and maintenance of Sterile Garment Cabinet Objective: To lay down the system for the ordinary operation, cleansing and protection of the Sterile Garment Cabinet (SGC). Scope: This SOP is relevant operation cleansing and protection of the Sterile Garment Cabinet present in the microbiology lab. Responsibility: Chemist or above …

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SOP on Operation, Calibration, Cleaning and Maintenance of LAF

SOP on Functioning, Calibration, Cleaning, and Maintenance of LAF Objective: Technique for functioning, Calibration, Cleaning, and Maintenance of LAF. Scope: This SOP is relevant for the Operation, Calibration, Cleaning, and Maintenance of LAF in the Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head …

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SOP on Maintenance and usage of Reference cultures

SOP on Maintenance and usage of Reference cultures Objective: SOP on Maintenance and usage of Reference cultures. Responsibility: Officer or above of Microbiology Laboratory: Accountability: Head – Microbiology section. Head – Quality control. Procedure Procurement of Lyophilized Cultures Reference Cultures can be procured from following suppliers: ATCC: American Type Culture …

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Market complaints and product recall

Market complaints and product recall DEFINITION: A ‘Complaint’ simply designates, that something is wrong or not good enough. Generally in the pharmaceutical industry, complaints are regarding the quality of drug products. A complaint shows customer dissatisfaction about a product and consequently, about a company. Principle: All complaints and other information …

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Rubber Bung Processor Cum Sterilizer

Rubber Bung Processor Cum Sterilizer • HPHV Steam Sterilizer is used for sterilization of liquid, Hard and Hard Porous Material, Glass ware, drugs and surgical instrument used a pharmaceutical. It is also used For Sterilization of containers, vessels, linen, rubber articles culture media etc. • Provide with Sliding doors with …

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Cleaning of Factory Footwear

Cleaning of Factory Footwear Objective To lay down a procedure for Cleaning of Factory Footwear.  Scope This Standard Operating Procedure is applicable for cleaning of factory footwear in the formulation plant. Responsibility Housekeeping personnel is responsible to follow the procedure mentioned in SOP. HR Department is responsible for implementation of …

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