Tag: technology transfer in pharmaceutical industry pdf

Record of pressure in the microbiological laboratory in Pharma

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Record of pressure in the microbiological laboratory in Pharma To lay down the procedure of pressure record in the microbiological laboratory rooms. It is for monitoring the pressure difference between rooms of the lab. PROCEDURE: The pressure difference between the rooms is determined by the laboratory using a manometer Magnehelic. Before the account for the…

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Microbiology

Operation of pass box transferring of materials in Microbial lab of Pharma Industry

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Operation of pass box. transferring of materials in Microbial lab of Pharma Industry To lay down the pass-box operation procedure. This procedure is applicable when passing the material from one room to another using the pass-box. PROCEDURE: General cleaning After use, wipe the inside of the folded-box clean dry rag. After completing the mechanical cleaning…

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Microbiology

Safety working in the microbiological laboratory In Pharma

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Safety working in the microbiological laboratory In Pharma Providing a safe work environment to employees. The personnel of the microbiological laboratory. PROCEDURE: To work in the laboratory allowed a person for a recent preliminary medical examination, an introduction, and initial instruction in the workplace on occupational safety, special education, if necessary (including safety), and validation…

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Microbiology

Requirements to personnel of the miсrobiological laboratory

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Requirements for personnel of the miсrobiological laboratory Set requirements to personnel  of the microbiological laboratory Determine the qualifications of personnel, their rights and responsibilities, and also official relationships. PROCEDURE Requirements, rights, and duties of employees of the microbiological laboratory are determined in duty regulations. On arrival at work, the employee must be acquainted with corresponding…

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Microbiology

Manufacturing Operations and Controls In Pharma Industry

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Manufacturing Operations and Controls In Pharma Industry All manufacturing operations shall be carried out under the supervision of technical staff approved by the Licensing Authority. Each critical step in the process relating to the selection, weighing, and measuring of raw material addition during various stages shall be performed by trained personnel under the direct personal…

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Uncategorized

Disposal of waste

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Disposal of waste Disposal of waste means eliminating, scraping, recycling, or destroying unwanted materials known as waste that is generated from the manufacturing, packing, and warehousing of industrial pharmaceutical products. Following the correct methods for waste disposal will ensure lesser pollution and hazards to the environment. All the pharmaceutical waste shall be collected initially in…

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Production

Handling of external laboratory activities

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Handling of external laboratory activities To lay down a procedure for qualifying, auditing, sending samples with reference to testing procedures, and obtaining the results for the same. This SOP is applicable to all the external laboratories to which the samples are sent for testing due to the non-availability of in-house facilities/resources. PROCEDURE The external laboratory…

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Quality Control

EXCEL SHEET VALIDATION

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EXCEL SHEET VALIDATION The objective of this procedure is to establish the guideline for the validation of Microsoft Excel spreadsheets use for calculating the product quality parameters. This procedure covers the validation procedure for validation of Microsoft Excel spreadsheets use for calculating the product quality parameters in QA. Procedure Spreadsheets used for simple calculations (e.g:…

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Quality Control

CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING

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CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING The objective of this procedure is to establish the guideline for the calibration of dies required for blend sampling. This SOP is applicable to dies required for a sampling of the blend for validation batches manufactured in the Pharma Industry. Procedure Take a die to be calibrated for…

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Quality Assurance

HANDLING COUNTERFEIT/FALSIFIED MATERIALS

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HANDLING COUNTERFEIT/FALSIFIED MATERIALS To lay down a standard procedure that describes handling counterfeit/falsified materials. Applicable for the procedure of handling counterfeit/falsified materials. PROCEDURE The received material should undergo incoming inspection. If the incoming inspection results of the materials are unsatisfactory, the QA department initiates the investigation of the case. The Authorized person prepares a report…

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Production

Shipping Validation

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Shipping Validation Objective The objective of this study is to establish a procedure to record temperature data to ensure that transportation conditions have not adversely affected a product until it reaches the Central Warehouse when transported as per regular Shipment practice. Scope The protocol shall be applicable at the formulation Plant. The Shipping (Transportation) validation…

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Warehouse

AUTOCLAVE – MAINTENANCE AND VALIDATION

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AUTOCLAVE – MAINTENANCE AND VALIDATION. INTRODUCTION An autoclave is a device to sterilize equipment and supplies by subjecting them to high pressure steam at 121° C or more. It was invented by Charles Chamberland in 1879,although a precursor known as the steam digester was created by Denis Papin in 1679. The term autoclave is also…

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Production

WEIGHING ON AN ANALYTICAL BALANCE AS PER USP (1251)

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WEIGHTS AND BALANCES AND ANALYTICAL BALANCE The requirements for weights into conformity with American National Standard ANSI/ASTM E617, “Laboratory Weights and Precision Mass Standards.” Pharmacopeial tests and assays require balances that vary in capacity, sensitivity, and reproducibility. Unless otherwise specified, when substances are to be “accurately weighed” for Assay, the weighing is to be performed…

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Quality Control

Pharma Definitions

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Pharma Definitions 1. Aseptic processing A process performed maintaining the sterility of a product that is assembled from components, each of which has been sterilized by steam, dry heat, ionizing radiation, gas or sterile filtration. This is achieved by using conditions and facilities designed to prevent microbiological contaminants. 2. Bioburden The total number of micro-organisms…

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Quality Assurance

Operation and calibration procedures of melting point apparatus

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Purpose : Operation and calibration procedures of melting point apparatus SCOPE : Is applicable to the operation and calibration procedures of melting point apparatus RESPONSIBILITY : Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP ACCOUNTABILITY:  QC Head and QA Head shall be accountable for compliance of this SOP ATTACHMENTS…

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Quality Control

Procedure for personnel management system

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Purpose : To lay down a procedure for personnel management system. SCOPE : This SOP is applicable to the Human Resource Department. RESPONSIBILITY : Head Human Resource and Management. ACCOUNTABILITY : Quality Assurance Head ATTACHMENTS : Not applicable PROCEDURE: Personnel department will lay out the personnel management system which includes identification of staff position, the responsibilities…

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Quality Assurance

Procedure for cleaning of microbiological Laboratory

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PURPOSE: procedure for cleaning of microbiological Laboratory. SCOPE: To maintain high standards of cleaning in microbiology lab. RESPONSIBILITY : Done by: Microbiologist. ACCOUNTABILITY : Quality Control Head ATTACHMENT :ANNEXURE-I   RECORD OF HOUSE KEEPING IN MICROBIOLOGY LABORATORY PROCEDURE: Cleaning shall be done daily Floors shall be mopped daily with water containing disinfectants. Possible use of any disinfecting…

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Microbiology