Performance Qualification for Automatic Strip Packing Machine TABLE OF CONTENTS Approval Objective Responsibility System Description – Equipment Identification & Description of Operation Standard Operating Procedure Established During Operation Qualification Validation Plan and Methodology Performance Qualification Procedure -1.Effect of Sealing Temperature 2. Effect of Sealing Temperature 3.Effect of Vibration Deviation and …

Questions and Answers on coronaviruses (COVID-19) WHO 1.0 Question : What is a coronavirus? Answer :  Coronaviruses are a large family of viruses which may cause illness in animals or humans.  In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases …

SOP on Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home Published 9 April 2020 From: Medicines and Healthcare …

WHO Pharma Guideline for Basic protective measures against new coronavirus and Myth busters To prevent infection and to slow transmission of COVID-19, do the following: Wash your hands regularly with soap and water, or clean them with alcohol-based hand rub. Maintain at least 1 metre distance between you and people …

SOP for Performance Qualification for Auto Coater 48’’ GMP Model TABLE OF CONTENTS 1.Approval 2.Objective 3.Responsibility 4.System Description – 1.Equipment Identification 2.Description of Operation 5.Standard Operating Procedure  Established During Operation Qualification 6.Validation Plan and Methodology 7.Performance Qualification Procedure Gun Distance from Bed RPM of Peristaltic pump and Spray Rate Effect …

SOP For Site Acceptance Test Protocol for Tablet Compression Machine machine name :  35 STN “B” TOOLING TAB COMPRESSION  MACHINE     Client Name & address :     document name : SITE ACCEPTANCE TEST PROTOCOL     PROTOCAL no. :     Revision no. : 00     MACHINE …

1.0 OBJECTIVE: To lay down a Standard Operating Procedure to prevent the spread of COVID 19 infection at the workplace. 2.0 SCOPE: This SOP is applicable to cover all the individuals entering into plant 3.0 RESPONSIBILITY: HR department to verify and ensure compliance of the procedure. All individual reporting to …

Compression Machine FAT (Factory Acceptance Test) Compression Machine FAT – The purpose is to identify the quality acceptance tests performed at the suppliers’ facilities. Ensuring the compression runs well at startup is an important role of the equipment supplier. Proper design and fabrication are critical, but equally important is a …

SOP For Performance Qualification for Tablet Compression Machine TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Machine Speed 6.2 …

SOP For MFR For Ornidazole Tablets 500 mg Label Сlaim Manufacturing Formula List of Equipment Manufacturing Instructions Manufacturing Process Flow Chart Manufacturing Process Details Packaging Finished Product Specifications Procedural Changes   Label Сlaim  Product Ornidazole Tablets 500 mg Strength 500 mg Label сlaim Each Film uncoated tablet contains: Ornidazole …………500 …

STABILITY STUDY PROTOCOL THIS PROTOCOL IS: Lisinopril and Hydrochlorothiazide tablets 10+12.5 mg CONTENTS: Each uncoated tablet contains: Lisinopril dihydrate equivalent to Lisinopril 10mg Hydrochlorothiazide                                           12.5mg SHELF LIFE: 24 months DOSAGE FORM: Tablet MANUFACTURED AT: TYPE OF STABILITY STUDIES: Accelerated stability studies 40 + 20C / 75 + 5 …

MASTER MANUFACTURING FORMULA OF LISINOPRIL & HYDROCHLOROTHIAZIDE 10+12.5 MG TABLETS Contains Label Сlaim Manufacturing Formula List of Equipment Manufacturing Instructions Manufacturing Process Flow Chart Manufacturing Process Details Packaging Finished Product Specifications Procedural Changes   Label Сlaim  Product Lisinopril & Hydrochlorothiazide Tablets Strength 10+12.5 mg Label сlaim Each tablet contains: Lisinopril …

OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Pre-Approval Overview Purpose Requalification System Distribution System Description Operational Qualification Procedure Pre Requisite for OQ Test Test Equipments Qualification of Execution Team Inspection Checklist Operational Qualification Instrument Calibration Key Functionality Operational Checks SOP verification Deficiency, if any …

Objective: To lay down the procedure for Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for Transfer of technology for Analytical Methods from ARD to Formulation Unit. Responsibility: Responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol for Analytical Method transfer. Execution of …

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Disinfection Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores. Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on …

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for Transfer of Technology for Manufacturing Process. Scope: This procedure is applicable for Transfer of technology (i.e. for Manufacturing process) from sending unit (F R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibility of Sending Unit …

INSTALLATION   QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary & Conclusion 10 Abbreviations …

DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM TABLE OF CONTENTS DESIGN QUALIFICATION PROTOCOL APPROVAL INTRODUCTION OBJECTIVE: SCOPE RESPONSIBILITY BASIS OF DESIGN SYSTEM DESCRIPTION SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS PANEL INTERLOCKS AND OPERATIONAL LOGICS CRITICAL SAFETY REQUIREMENTS SAMPLING PLAN SANITISATION CYCLE LIST OF APPROVED MAKES DESIGN QUALIFICATION APPROVAL …

USFDA WARNING LATTER 2019 – DRUGS   Reference Number Short Description Critical Observation and discripancies 21 CFR 211.22(d) Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. 21 CFR 211.192 Investigations of discrepancies, failures There is …