Risk Assessment HVAC Protocol
Risk Assessment HVAC Protocol
Risk Assessment HVAC Report
Risk Assessment HVAC Report
Risk Assessment Report Compressed Air
Risk Assessment Report Compressed Air
Risk Assessment Protocol Compressed Air
Risk Assessment Protocol Compressed Air
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
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
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
DOCUMENT AND DATA CONTROL PROCEDURE
DOCUMENT AND DATA CONTROL PROCEDURE DATA INTEGRITY AND DATA RELIABILITY
RISK Assessment of Purified Water Report
RISK Assessment of Purified Water Report RISK Assessment of Purified Water Protocol
RISK Assessment of Purified Water Protocol
RISK Assessment of Purified Water Protocol RISK Assessment of Purified Water Report
DATA BACKUP AND RESTORATION
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:…
USER ID PASSWORD POLICY
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…
USER DOMAIN ID
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…
Automatic Ink Jet Sticker Label Overprinting Machine
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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Operation, Cleaning and Overprinting of Semi- Automatic Carton Overprinting Machines
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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Handling and Storage of Empty Hard Gelatin Capsule Shells in Raw Material Store
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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MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE
MICROBIOLOGICAL CONTROL FOR EXCIPIENTS, DRUG PRODUCT AND DRUG SUBSTANCE PURPOSE: To describe microbiological test controls to be applied for outsourced and in house drug substances, drug products and excipients. SCOPE: This SOP is applicable to drug substances, drug product, sterile drug product and excipients tested for microbiological quality. RESPONSIBILITY: Microbiologist shall be responsible for carrying…
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MANAGEMENT OF RAW DATA
MANAGEMENT OF RAW DATA PURPOSE: To provide a procedure for recording, review, and storage of raw data at manufacturing sites. SCOPE: This SOP applies to all the raw data generated/collected during Warehousing, manufacturing/packaging operations, testing, environmental monitoring, operation and monitoring of equipment and utilities, calibrations, qualification and validation activities, cleaning, sterilization, and any other activity, which involve…
STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS
STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS PURPOSE: To describe a procedure for Storage and Disposal of Exhibit Batches of Drug Products. SCOPE: This standard operating procedure (SOP) is applicable to the exhibit batches of Drug Products manufactured and packed in the formulation manufacturing facilities. RESPONSIBILITY: Production: Transfers the exhibit batches to warehouse….
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Handling of Fallen off / Damaged Status labels
Handling of Fallen off / Damaged Status labels Objective: To lay down a procedure for Handling of Fallen off / Damaged Status labels. Scope This Standard Operating Procedure is applicable for Handling Fallen-off / Damaged Status labels of Raw Material /Packing material at the formulation plant. Responsibility Concerned Department personnel shall be responsible for following…
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