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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Liquid Bourne Particle counter (LBPC) Objective: To lay down the procedure for Cleaning, Operation, Maintenance, and Analysis of samples using LBP counter. Scope: This SOP is applicable for the Operation, Cleaning, Maintenance and Analysis of LBPC samples in the manufacturing department. Responsibility: Microbiologist / IPQA personnel are responsible for follow the procedure. …

Cartridge filter -Integrity Testing SOP Objective: To lay down a procedure for integrity testing of the cartridge filter. Scope: This SOP is applicable for integrity testing of cartridge filters in the formulation plant. Responsibility: Production officer / Executive Accountability: The production Head shall be accountable for compliance with SOP. Procedure Pre-Start-up …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -9 Question 1: What is robustness, and when should its evaluation be considered? Answer 1: Robustness is the measure of an analytical procedure’s reliability with respect to deliberate variations in method parameters. Its evaluation should be considered during the …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -8 Question 1: What validation approach can be used to validate an estimated value for the detection limit? Answer 1: An estimated value for the detection limit can be validated by the independent analysis of a suitable number of …