Tag: Macerata

SOP ON PROCEDURE FOR HANDLING OF BATCH BIFURCATION IN PHARMA

Posted on By shivpharma2016

SOP ON PROCEDURE FOR HANDLING OF BATCH BIFURCATION IN PHARMA OBJECTIVE: To lay down the Procedure for Handling of Ready for Filling (Blend) and Ready for Packing (Tablets) and Batch Bifurcation for primary Packing Area. SCOPE: This procedure is applicable for Handling of Ready for Filling (Blend) and Ready for Packing (Tablets) and Batch Bifurcation for primary…

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Production

SOP ON PROCEDURE FOR RECEIVING OF DISPENSED RAW MATERIAL IN PHARMA

Posted on By shivpharma2016

SOP ON PROCEDURE FOR RECEIVING OF DISPENSED RAW MATERIAL IN PHARMA OBJECTIVE: To lay down a procedure for receiving of dispensed raw material. SCOPE: This procedure is applicable for the receiving of dispensed raw material.. RESPONSIBILITY: It is the responsibility of the operator and production chemist to follow the procedure as prescribed in this SOP during dispensing…

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Production

SOP on Internal Labeling in Quality Control Department

Posted on By shivpharma2016

SOP on Internal Labeling in the Quality Control Department PURPOSE: To define procedures for Internal Labeling in the Quality Control Department. SCOPE: This procedure is applicable for Internal Labeling in the Quality Control Department. RESPONSIBILITY Analyst / QC – officer / Executive – QC: To Prepare and follow SOP Head QC: To ensure implementation of SOP….

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Quality Control

SOP for Preparation, Authorization, Revision, and control of specifications, Standard testing procedures and General test Procedures

Posted on By shivpharma2016

SOP for Preparation, Authorization, Revision, and control of specifications, Standard testing procedures, and General test Procedures PURPOSE: To lay down a standard procedure to describe the steps to be followed and persons involved in the preparation,  issuance,  revision, and control of   Specifications and Standard Testing Procedures. SCOPE: This procedure applies to the Quality control department….

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Quality Control

SOP on Entry and Exit procedure in Quality Control laboratory

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SOP on Entry and Exit procedure in Quality Control laboratory PURPOSE: To define procedures for entry and exit procedures in the laboratory/ Quality Control department. SCOPE: This SOP applies to the quality control department RESPONSIBILITY QC Person: To prepare and follow the SOP. Head QC: To ensure implementation of the defined system. PROCEDURE Entry Procedure:…

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Quality Control

SOP on Opening and closing of Quality Control Laboratory

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SOP on Opening and closing of Quality Control Laboratory PURPOSE: To define procedures for opening and closing of the Quality Control department. SCOPE: This SOP is applicable for the quality control department and includes a microbiology section,   instrument section, physical-chemical section, stability section, record, room, main entrance, etc. RESPONSIBILITY QC Person: To open & lock…

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Quality Control

SOP on Preparation of Placebo in Pharma

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SOP on Preparation of Placebo in Pharma PURPOSE: To provide guidelines for the preparation of a placebo in a pharmaceutical company. SCOPE: This procedure is applicable for the preparation of a placebo in a pharmaceutical company. Attachments Placebo Preparation Log Placebo Details Placebo preparation Record RESPONSIBILITY     : QC department person : For the preparation of…

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Quality Control

SOP ON MICROBIOLOGIST QUALIFICATION IN MICROBIOLOGY LAB

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SOP ON MICROBIOLOGIST QUALIFICATION IN MICROBIOLOGY LAB PURPOSE:  To provide a procedure for Best Microbiological Lab Practices in Microbiology Lab in Microbiology Lab. SCOPE: This procedure is applicable for Microbiologist Qualification in the microbiology Lab. ATTACHMENTS : Microbiologist Qualification Report Microbiologist Qualification Inward RESPONSIBILITY: Quality control Department Laboratory Attendant person (Microbiology Lab)/ Designee:  To follow…

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Microbiology

SOP ON BEST MICROBIOLOGICAL LAB PRACTICES IN MICROBIOLOGY LAB

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SOP ON BEST MICROBIOLOGICAL LAB PRACTICES IN MICROBIOLOGY LAB PURPOSE: To provide a procedure for Best Microbiological Lab Practices in Microbiology Lab in Microbiology Lab. SCOPE: This procedure is applicable for Best Microbiological Lab Practices in Microbiology Lab. RESPONSIBILITY: Quality Control Department Laboratory Microbiologist:  To follow this procedure during Best Microbiological Lab Practices in Microbiology Lab….

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Microbiology

SOP ON CLEANING AND DISINFECTION IN MICROBIOLOGY LAB

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SOP ON CLEANING AND DISINFECTION IN MICROBIOLOGY LAB PURPOSE:  To provide a procedure for Cleaning and Disinfection in Microbiology Lab. SCOPE: This procedure is applicable for Cleaning and Disinfection in the Microbiology Lab. CROSS-REFERENCE DOCUMENTS: Preparation and filtration procedure of disinfectant in microbiology lab. ATTACHMENTS: Cleaning Record of Classified/Non-Classified Area RESPONSIBILITY: The microbiologist/Designee/Lab attendant Person…

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Microbiology