Tag Archives: Ajmer

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 …

User requirement specification of stability chamber INDEX Objective Scope Basic of system Control system Temperature controller Humidity controller Pc/ printer interfacing unit Data logger Plc Door access system Control panel Safety controller for low /high temperature Optional accessories Software Water tank Printer Validation documentation Approval OBJECTIVE:    This document is to …

DISINFECTANT VALIDATION TABLE OF CONTENTS Protocol Approval Objective Acceptance Criteria Responsibilities Validation Methodologies Evaluation of test Result Re-validation Frequency Documentation Conclusion PROTOCOL APPROVAL  Name / Designation Prepared By Microbiologist Checked By Microbiology Manager. Quality Control Checked By Microbiology Manager. Quality Control Approved By Plant Manager Manager. Quality Assurance OBJECTIVE: To evaluate …

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 ensure that the UV is effective enough to kill the microorganisms on exposure to …

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 …

PROCESS VALIDATION PROTOCOL OF PARACETAMOL 500 MG CAPLTES Batch size: 8,000,00Tablets (480.00 kg) ,Shelf life: 36 Months, Reason for validation: Introduction of New Product at Site (8.0Lac.) Table of Contents Pre- approval Objective Scope Responsibilities Reference documents Key equipment / instrument detail (qualification / calibration) Product detail Master formula Process description Process …

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 OF PRESSURE VESSEL Equipment No’s.  Description Use Field Identification:  To be installed in medicament preparation room in soft gelatin block. (i) Room Temperature NMT 25ºC and RH NMT 60 % (ii)  Non flame proof. Salient Features Material of Construction All the contact parts preferably should be of …

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. …

Installation Qualification for Pass Box TABLE OF CONTENTS Approval Objective Responsibility Equipment Identification Equipment location Documentation Pre-requisite of Installation Qualification Installation Qualification Procedure System Description Procedure Installation Check List Inspection Check list Leveling and Alignment Material of Construction Check Points Guarantee / Warrantee Certificates Drawing Execution Identification of Standard Operating …

Operational Qualification for 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 classification. The product is provided with door interlocking system and minimum component of germicidal light …

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 …

Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance PAT FRAMEWORK PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final …