Tag: Al Jasrah

Training Requirements for Audit and Routine Practices in Pharmaceuticals

Posted on By Pharmaceutical Guidanace

Training Requirements for Audit and Routine Practices in Pharmaceuticals Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in…

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Audit and Guideline

Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals

Posted on By Pharmaceutical Guidanace

Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of drug products. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become…

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Audit and Guideline

Manufacturing Procedure of Ornidazole Tablets

Posted on By Pharmaceutical Guidanace

 Manufacturing Procedure of Ornidazole Tablets   Bill of Material Ingredient Pharmaceutical role Ornidazole Active Microcrystalline Cellulose Diluent Lactose Monohydrate Diluent Silica, Colloidal Anhydrous Surfactant Povidone (K-30) Binder Water, Purified Vehicle Sodium Lauryl sulphate Surfactant Talc Granular former Magnesium Stearate Lubricant Croscarmellose Sodium Disintegrating Opadry Green Coloring Agent Manufacturing Procedure  Step – I:-Sift, Lactose Monohydrate, Silica,…

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Production

Manufacturing Procedure and Flow chart of Metformin Hydrochloride Extended – Release Tablets USP 1000 mg

Posted on By Pharmaceutical Guidanace

Manufacturing Procedure of Metformin Hydrochloride Extended-Release Tablets USP 1000 mg     Bill of Material: Batch Size:- 100000 Tablets Ingredient Standard Quantity  Per batch In kg METFORMIN HYDROCHLORIDE 100.60* CARMELLOSE SODIUM 10.00 PURIFIED WATER 18.60 HYPROMELLOSE 26.00 CELLULOSE,MICROCRYSTALLINE (DIRECTLY  COMPRESSIBLE,PH 102) 9.5 MAGNESIUM STEARATE 1.5 POVIDONE 1.5 SILICA , COLLOIDAL .ANHYDROUS 1.5 * Given quantity of Metformin…

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Production

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL

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CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL Sec. 210.1-Status of current good manufacturing practice regulations (a)  The minimum current good manufacturing practice for methods to be used in the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that…

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Audit and Guideline

Validation of Sterilization Process in Autoclave

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Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL      Validation of Sterilization  Process in Autoclave (Loaded chamber)  Purpose: To provide the procedures to be followed for study of heat distribution studies in the loaded chamber of Autoclave.  Scope:  This procedure is applied to all Autoclaves used to sterilize Containers or Equipment used for the aseptic processing…

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Uncategorized, Production, Validation & Qualification

Procedure for measurement of fill weight during batch filling

Posted on By Pharmaceutical Guidanace

Procedure for measurement of fill weight during batch filling Objective: To lay down the procedure for measurement of fill weight during batch filling. Scope: This SOP is applicable for measurement of fill weight during batch filling in Injectable department. Responsibility: Operators/Technician – Responsible for measurement of fill weight during batch filling. Executive /Officers production –…

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Production

Manufacturing Process Development as per ICH -Q11

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Manufacturing Process Development as per ICH -Q11 The approaches to developing and understanding the manufacturing process of the drug substance, and  provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2 –3.2.S.2.6 (ICH M4Q). All the aspects of development and manufacture that pertain to drug substance, including the presence…

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Audit and Guideline

Qualification For Stability Chamber

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Stability Chamber Stability Chambers serve as specialized equipment used for testing various products and determining their shelf life, such as drugs, electrical components, and industrial materials. These chambers allow for the adjustment of parameters like temperature and humidity to conduct thorough checks under different conditions. Since different products require specific testing conditions, it is not…

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Validation & Qualification

DISINFECTANT VALIDATION

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DISINFECTANT VALIDATION To evaluate the efficiency of disinfectants that are being used for the surface and area sanitization of controlled and critical clean rooms. The disinfectants when used as per the recommendations of the manufacturer for dilution and the contact time should be able to inhibit the growth of the test microorganisms. TABLE OF CONTENTS…

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Microbiology, Validation & Qualification

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

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PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM OBJECTIVE The objective of this study is to determine the efficacy of UV germicidal lamp of Laminar air flow and pass box with known microorganism. This ensures that the UV is effective enough to kill the microorganisms on exposure to a defined period and…

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Microbiology, Validation & Qualification

Unit Dose Sampling Procedure for Blend Uniformity

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Unit Dose Sampling Procedure for Blend Uniformity OBJECTIVE To lay down the procedure for collecting unit dose blend samples for evaluation of blend uniformity so as to ensure accurate and consistent sampling. RESPONSIBILITY : Officer – Quality Assurance to collect the samples. Head of Quality Assurance to ensure compliance. PROCEDURE: Unit dose sampling procedure for…

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Quality Assurance

Worst case identification for cleaning validation

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Worst case identification for cleaning validation OBJECTIVE: Objective of this SOP is to provide the procedure to be followed during worst case identification for cleaning validation. It also includes updating of API solubility – potency matrix, calculation of acceptable residue levels during cleaning validation. SCOPE: This SOP covers the worst case selection criteria for validation…

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Quality Assurance

Prospective Process Validation of Paracetamol Tablets

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Paracetamol  Paracetamol/acetaminophen is the most commonly used analgesic and antipyretic drug, It is the drug of choice in patients who cannot be treated with non-steroidal anti-inflammatory drugs (NSAID), such as people with bronchial asthma, peptic ulcer disease, hemophilia, salicylate-sensitized people, children under 12 years of age, pregnant or breastfeeding women. It is recommended as a…

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Validation & Qualification

VALIDATION MASTER PLAN

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VALIDATION MASTER PLAN CONTENTS SR. NO. CONTENTS PAGE NO. 1 APPROVAL 2 INTRODUCTION 3 VALIDATION POLICY 4 OBJECTIVE 5 SCOPE 6 VALIDATION RESPONSIBILITIES 6.1 Validation Team Constitution 7 FACILITY DESCRIPTIONS AND DESIGN 7.1 General Description and Design Concept 7.2 Description of Products 7.3 Description of Process 7.4 Description of Equipments 8 VALIDATION PROGRAM AND SUPPORTING…

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Quality Assurance

USER REQUIREMENT SPECIFICATION (URS) OF PRESSURE VESSEL

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USER REQUIREMENT SPECIFICATION The User Requirements Specification (URS) outlines the business needs for what the equipment’s users need. URS are typically drafted early in the validation phase, often before the system is developed. URS is developed by the system owner and the end-users, with contributions from Quality Assurance. The requirements detailed in the URS are…

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Validation & Qualification

SOP for operation of Metal Detector for automatic capsule filling machine

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SOP for operation of Metal Detector for automatic capsule filling machine Objective: To lay down a procedure for operation of metal detector. Scope: This SOP is applicable for the operation of metal detector to the formulation plant of  PHARMACEUTICAL Company. Responsibility: Production Operator/ Technician – For operation of the machine. Production Officer/Executive-To ensure that operation…

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Production

Installation Qualification for Pass Box

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Pass Box A pass box is a component of a cleanroom setup designed to move materials from one side to another within a controlled setting to prevent contamination through the air. Its sole function is to transfer materials from one side to the other without causing any contamination issues, and it automatically removes any particles…

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Validation & Qualification