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: … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more
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. … Read more
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 … Read more
Operation and Cleaning of Refrigerator Objective: To lay down a procedure for the Operation and Cleaning of the Refrigerator in the Raw Material Store. Scope: This Standard Operating Procedure is applicable for the operation and cleaning of the Refrigerator in the Raw Material Store at the formulation plant. Responsibility Raw material Store personnel shall be … Read more
Cleaning of SS Trolleys, Pallets and Racks Objective: To lay down a procedure for cleaning SS Trolleys, Pallets, and Racks Scope: This SOP is applicable for cleaning SS Trolleys, Pallets, and Racks in the Raw Material Store/packing material/finished goods at the formulation plant. Responsibility Store personnel shall be responsible for following the procedure mentioned in … Read more
SYSTEM MAINTENANCE PROCEDURE FOR STABILITY CHAMBER GENERAL MAINTENANCE ONLY TRAINED AND SKILLED PERSONS SHOULD MAINTAIN THE MACHINE. Follow work permit procedure before any maintenance work. Thermolab will not be responsible if the same is ignored. Check whether the stability chamber is clean from inside and outside after use. Check the humidity tank, kettle heater and … Read more
Housekeeping OBJECTIVE: To lay down a standard operating procedure for Housekeeping in the factory. SCOPE: This SOP is applicable for Housekeeping. RESPONSIBILITY: Officer/ Executive – HR ACCOUNTABILITY: Manager/ Head- QA / All Concerned HOD PROCEDURE: CLEANING TOOLS: Mops, Wiper, Glass wiper, Glass cleaner and Vacuum Cleaner and plastic broom shall be used for cleaning. PREPARATION OF DISINFECTANTS AND … Read more
PROCEDURE FOR HANDLING OF EXTERNAL AUDITS OBJECTIVE: The purpose of this SOP is to lay down the procedure for handling of external inspections / audits by the agencies and customers for various products. SCOPE: This procedure is applicable for handling of external inspections / audits. RESPONSIBILITY: Site Head: To welcome auditors at opening meeting. To … Read more
HANDLING OF BIOHAZARDOUS MATERIAL IN MICROBIOLOGY LAB PURPOSE: To outline the procedure for Handling Biohazardous Material in the Microbiology Lab. SCOPE: This procedure is applicable for Handling Biohazardous Material in the Microbiology Lab. REFERENCE(S) & ATTACHMENTS REFERENCES In-House ISO 45001:2018 CROSS-REFERENCE DOCUMENTS Preparation, Review, Approval, Issuance & Retrieval of Standard Operating Procedures (SOPs) Change Control … Read more
HANDLING OF AUDIT TRAIL PURPOSE: This SOP describes the procedure for Handling of system audit trail/ Batch audit trail report which is generated by the manufacturing, packing, warehouse and utility equipment. SCOPE: This SOP is applicable to all manufacturing, packing, warehouse and utility equipment. RESPONSIBILITY: User Department: To prepare procedure for review of system audit … Read more
COMPUTERIZED SYSTEM LIFE CYCLE PURPOSE: The purpose of this procedure is to define the system life cycle methodology that shall be used while implementing GxP computerized system to ensure that system remains in state of validation throughout the system life cycle. SCOPE: This SOP is applicable for all GxP computerized system at all the manufacturing … Read more
HANDLING OF DATA INTEGRITY AUDIT OBSERVATIONS
AUDIT POINT Warehouse: Pictorial presentation not available in sampling change room (Minor) Manufacturer released /approved label not defaced (Minor) Policy for usage of raw materials having retest date claim by manufacturer not defined in in SOP (Minor) Dispensing scoop status label not available of cleaned on, previous product, Use up to Most of the tools … Read more