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, …

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 …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -7 Question 1: What are the possible approaches for determining the detection limit, and what determines their applicability? Answer 1: The possible approaches for determining the detection limit depend on whether the procedure is non-instrumental or instrumental. Approaches include …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -6 Question 1: How should accuracy be assessed in the quantitation of impurities? Answer 1: Accuracy should be assessed on samples (drug substance/drug product) spiked with known amounts of impurities. Question 2: What is considered acceptable when it is …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -5 Question 1: How is the specified range determined in an analytical procedure? Answer 1: The specified range in an analytical procedure is typically derived from linearity studies and depends on the intended application of the procedure. It is …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -4 Question 1: How can specificity be demonstrated in chromatographic procedures? Answer 1: Specificity in chromatographic procedures can be demonstrated by using representative chromatograms where individual components are appropriately labeled. Critical separations should be investigated, and specificity can be …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -3 Question 1: What is the purpose of the ICH Q2 discussed? Answer 1: The purpose of the ICH q2 is to provide guidance and recommendations on how to consider various validation characteristics for each analytical procedure, complementing the …

Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -2 Question 1: What does accuracy of an analytical procedure express? Answer 1: The accuracy of an analytical procedure expresses the closeness of agreement between the value accepted as a true or reference value and the value found. It …