SOP

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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 …

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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 …

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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, …

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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 …

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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

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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  

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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 …

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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 …

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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 …

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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 …

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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 …

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Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

Qualification For Walk In Chamber ( STABILITY DATA ACQUSITION SOFTWARE) Introduction Purpose The purpose of this Qualification Plan (QP) is to define the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Testing activities for the qualification of WALK IN CHAMBER, STABILITY DATA ACQUSITION SOFTWARE to be deployed at Quality …

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DISINFECTANT VALIDATION

DISINFECTANT VALIDATION TABLE OF CONTENTS  Section No Topics Page No 1.0 Protocol Approval 2.0 Objective 3.0 Acceptance Criteria 4.0 Responsibilities 5.0 Validation Methodologies 6.0 Evaluation of test Result 7.0 Re-validation Frequency 8.0 Documentation 9.0 Conclusion PROTOCOL APPROVAL   Name /  Designation  Signature  Date  Prepared By Microbiologist      Checked By  Microbiology …

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PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM INDEX PART –I                                                                                                 Page no. Objective Brief Description Purpose Procedure Acceptance criteria PART –II Data generation for viable count PART –III Summary Recommendation Attachments PART-I  1.0          OBJECTIVE The objective of this study is to determine the efficacy of  …

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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: …

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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 …

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Prospective Process Validation

Prospective Process Validation I. INTRODUCTION Validation is an essential procedure that demonstrates that a manufacturing process operating under defined standard conditions is capable of consistently producing a product that meets the established product specifications. Process validation is establishing documented evidence that provides a high degree of assurance that a specific process  will …

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VALIDATION MASTER PLAN

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 …

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USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL 150 L

USER REQUIREMENT SPECIFICATION OF PRESSURE VESSEL 150 L S. No Table of Contents 1 General 2 Salient Features 3 Operational requirements 4 Utilities 5 Maintenance 6 Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery  TECHNICAL S. No. Parameters Requirement Specifications 1 1.1. General Equipment No’s.  1.2 Description 1.3 Use …

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SOP for operation of Metal Detector for automatic capsule filling machine

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. …

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