Non Conformance and Failure Investigation Checklist in pharmaceutical Products Product Name : Batch No. : …
Read More »OOS Investigation Checklist
OOS Investigation Checklist Checklist for investigation of out of specification Sampling: Is performance against written procedure carried out? Are the cleaned sampling equipments used? Are the cleaned containers used for collection of samples? Is the sample integrity maintained until testing? Is composite sample prepared correctly? SAMPLE PREPARATION: Is correct weighing …
Read More »DATA INTEGRITY – QUESTIONS AND ANSWERS
DATA INTEGRITY – QUESTIONS AND ANSWERS 1. Please clarify the following terms as they relate to CGMP records: 1.A) What is “data integrity”? Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). …
Read More »Data Integrity Guidance in Pharmaceuticals
Data Integrity Guidance Good data management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable. The organisational culture should ensure data is complete, consistent and accurate in all its forms, i.e. paper and electronic Organisations are not …
Read More »Training Requirements for Audit and Routine Practices in Pharmaceuticals
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 …
Read More »Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals
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, …
Read More »Manufacturing Procedure of Ornidazole Tablets
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 …
Read More »MANUFACTURING PROCESS FLOW CHART (Coated tablets)
MANUFACTURING PROCESS FLOW CHART (Coated tablets) Thank you for visit and for more pharma updates click here – https://pharmaguidances.com
Read More »MANUFACTURING PROCESS FLOW CHART (Uncoated tablets)
MANUFACTURING PROCESS FLOW CHART (Uncoated tablets) Thank you for visit and for more pharma updates click here – https://pharmaguidances.com
Read More »Manufacturing Procedure and Flow chart of Metformin Hydrochloride Extended – Release Tablets USP 1000 mg
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 …
Read More »CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL
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 …
Read More »Validation of Sterilization Process in Autoclave
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 …
Read More »Procedure for measurement of fill weight during batch filling
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 …
Read More »Manufacturing Process Development as per ICH -Q11
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 …
Read More »Qualification For Stability Chamber ( STABILITY DATA ACQUSITION SOFTWARE)
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 …
Read More »DISINFECTANT VALIDATION
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 …
Read More »PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM
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 …
Read More »Unit Dose Sampling Procedure for Blend Uniformity
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: …
Read More »Worst case identification for cleaning validation
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 …
Read More »Prospective Process Validation
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 …
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