Tag Archives: Umm Lekhba

MANUFACTURING PROCESS FLOW CHART (Uncoated tablets)   Thank you for visit and for more pharma updates click here – https://pharmaguidances.com  

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 …

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 …

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 loaded chamber of Autoclave.  Scope :  This procedure is applies to all Autoclaves used to sterilize Containers or Equipment’s used …

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 …

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 …

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 …

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 …

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 …

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: …

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 …

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. …

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 …

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 …

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. …

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 …

Pass Box The static pass-through hatch is used wherever transfer of material is required in between the clean room and non-clean room or in between the clean room if different classifications. The product is provided with a door interlocking system and a minimum component of germicidal light may be fitted …

MANAGEMENT REVIEW OF QUALITY METRICS Management review of quality Metrics procedure provides Monthly/ Quarterly Management Review and assessment of the performance of Quality and GMP systems. This document describes the activities of the Quality review meeting. SCOPE OF MANAGEMENT REVIEW OF QUALITY METRICS: This procedure applies to all facilities related …

Temperature Mapping Temperature mapping involves systematically assessing temperature changes within a specific area. This area ranges from warehouses for storing temperature-sensitive pharmaceuticals to critical laboratory incubators needed for successful experiments. The goal is to detect potential areas of excessive heat or cold that may pose a risk to the quality …

Types of liquid column chromatography( HPLC) The type of liquid column chromatography (HPLC) can be classified on the nature of the stationary phase and the separation process. There Can be classified into three types Adsorption chromatography Ion-exchange chromatography Size exclusion chromatography Adsorption chromatography In adsorption chromatography the stationary phase is an …