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Risk assessment for handling of corticosteroids

Posted on November 20, 2024 By Pharmaceutical Guidanace

Risk assessment for handling of corticosteroids

Risk Assessment

RISK ASSESSMENT FMEA/FMECA FOR MEDIA FILL

Posted on November 20, 2024November 20, 2024 By Pharmaceutical Guidanace

RISK ASSESSMENT FMEA/FMECA FOR MEDIA FILL ACTIVITY

Risk Assessment

RISK ASSESSMENT PROTOCOL FOR RESPULE LINE

Posted on November 20, 2024 By Pharmaceutical Guidanace

RISK ASSESSMENT PROTOCOL FOR  RESPULE LINE A risk assessment is a method to assess and characterize the critical parameters in the functionality of a System or Process. Therefore, risk Assessment is a key element in the process and validation approach. Added in product manufacturing process shall be evaluated to identify critical risk at various stages of…

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Risk Assessment

RISK ASSESSMENT PROTOCAL FOR STERILE FORMULATION FACILITY

Posted on November 20, 2024November 20, 2024 By Pharmaceutical Guidanace

RISK ASSESSMENT PROTOCAL FOR STERILE FORMULATION FACILITY A risk assessment is a method to assess and characterise the critical parameters in the functionality of a System or process. Therefore, risk Assessment is a key element in the process and validation approach. In the Area modification, risk analyses are performed as basic GMP/EHS-Risk Assessment, which shall help…

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Risk Assessment

Risk Assessment HVAC Protocol

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
Risk Assessment HVAC Protocol

Risk Assessment HVAC Protocol

Risk Assessment

Risk Assessment HVAC Report

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
Risk Assessment HVAC Report

Risk Assessment HVAC Report

Risk Assessment

Risk Assessment Report Compressed Air

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
Risk Assessment Report Compressed Air

Risk Assessment Report Compressed Air

Risk Assessment

Risk Assessment Protocol Compressed Air

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
Risk Assessment Protocol Compressed Air

Risk Assessment Protocol Compressed Air

Risk Assessment

SELF-INSPECTION PROGRAMME

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
SELF-INSPECTION PROGRAMME

SELF-INSPECTION PROGRAMME To describe the procedure for scheduling, conducting a self-inspection activity, and implementing corrective/preventive measures and effective follow-up actions towards the non-compliances observed. DATA INTEGRITY AND DATA RELIABILITY  

Quality Assurance

HANDLING OF EXTERNAL AUDIT OBSERVATIONS AND ITS COMPLIANCE

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
HANDLING OF EXTERNAL AUDIT OBSERVATIONS AND ITS COMPLIANCE

HANDLING OF EXTERNAL AUDIT OBSERVATIONS AND ITS COMPLIANCE EXTERNAL AUDIT OBSERVATIONS -Compliance shall be filled in proper QMS documents such as CAPA format, Investigation form, deviation, Change control and summary of CAPA shall mentioned in Audit Compliance Report. DATA INTEGRITY AND DATA RELIABILITY

Quality Assurance

DATA INTEGRITY AND DATA RELIABILITY

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
DATA INTEGRITY AND DATA RELIABILITY

DATA INTEGRITY AND DATA RELIABILITY Data Integrity:  The extent to which all data are complete, consistent, and accurate throughout the data lifecycle. Data integrity arrangements must ensure that the accuracy, completeness, content, and meaning of data is retained throughout the data lifecycle. DOCUMENT AND DATA CONTROL PROCEDURE

Quality Assurance

DOCUMENT AND DATA CONTROL PROCEDURE

Posted on November 12, 2024November 12, 2024 By Pharmaceutical Guidanace
DOCUMENT AND DATA CONTROL PROCEDURE

DOCUMENT AND DATA CONTROL PROCEDURE DATA INTEGRITY AND DATA RELIABILITY

Quality Assurance

RISK Assessment of Purified Water Report

Posted on November 8, 2024November 12, 2024 By Pharmaceutical Guidanace
RISK Assessment of Purified Water Report

RISK Assessment of Purified Water Report RISK Assessment of Purified Water Protocol  

Risk Assessment

RISK Assessment of Purified Water Protocol

Posted on November 8, 2024November 12, 2024 By Pharmaceutical Guidanace
RISK Assessment of Purified Water Protocol

RISK Assessment of Purified Water Protocol RISK Assessment of Purified Water Report

Risk Assessment

DATA BACKUP AND RESTORATION

Posted on October 8, 2024November 4, 2024 By Pharmaceutical Guidanace

DATA BACKUP AND RESTORATION OBJECTIVE: To lay down the procedure of data backup & restoration of the Lab Instrument Computer Systems Data Backup Server. SCOPE: The scope of this document is to provide the procedure and alternative procedure for data backup and retrieval from Storage Server Backup Server for QC, Stability, and Micro departments. RESPONSIBILITY: IT Administrator:…

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IT SOP

USER ID PASSWORD POLICY

Posted on October 7, 2024November 4, 2024 By Pharmaceutical Guidanace

USER ID PASSWORD POLICY OBJECTIVE: This document provides procedure for issuing user ID’s and Passwords to access Computerized System and procedure to be followed to create, maintain and obsolete user account. SCOPE: This SOP-IT is applicable to all computerized Systems covered under GxP & non GxP. RESPONSIBILITY: T. Administrator: Responsible for implementation of procedures outlined in this…

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IT SOP

USER DOMAIN ID

Posted on October 7, 2024November 4, 2024 By Pharmaceutical Guidanace

USER DOMAIN ID OBJECTIVE: The objective of this policy is to lay down the procedure for issuing domain, internet account ID and password to authorized persons without affecting confidentiality and integrity of organization information residing on Computerized Systems over network. SCOPE: Accounts issued to all employees and contract employees are covered under the scope of…

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IT SOP

Automatic Ink Jet Sticker Label Overprinting Machine  

Posted on May 19, 2024November 10, 2024 By Pharmaceutical Guidanace

Operation, Cleaning, And Overprinting of Automatic Ink Jet Sticker Label Overprinting Machine  Objective: To lay down a procedure for the Operation, Cleaning, and Overprinting of Automatic Ink Jet Sticker Label Overprinting Machine. Scope: This Standard Operating Procedure is applicable for the Operation, Cleaning, and Overprinting Record of the Automatic Ink Jet Sticker Label Overprinting Machine…

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Production

Operation, Cleaning and Overprinting of Semi- Automatic Carton Overprinting Machines

Posted on May 19, 2024November 4, 2024 By Pharmaceutical Guidanace

Operation, Cleaning, and Overprinting of Semi- semi-automatic carton Overprinting Machines Objective: To lay down a procedure for Operation, Cleaning, and Overprinting of Semi-Automatic Carton Overprinting Machines. Scope: This Standard Operating Procedure is applicable for Operation, Cleaning, and Overprinting Record of Semi-Automatic Carton Overprinting Machine & Semi-Automatic Carton Overprinting Machine. Responsibility Packing Material Store and production…

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Warehouse

Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store

Posted on May 15, 2024November 4, 2024 By Pharmaceutical Guidanace

Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store Objective To lay down a procedure for Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store to prevent them from drying and embattlement or the absorption of moisture. Scope This Standard Operating Procedure is applicable in Raw Material…

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Warehouse

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Recent Posts

  • Risk assessment for handling of corticosteroids
  • RISK ASSESSMENT FMEA/FMECA FOR MEDIA FILL
  • RISK ASSESSMENT PROTOCOL FOR RESPULE LINE
  • RISK ASSESSMENT PROTOCAL FOR STERILE FORMULATION FACILITY
  • Risk Assessment HVAC Protocol




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