Batch Manufacturing Records Review Check all sections of the Batch Manufacturing Record (BMR), for the accuracy and correctness of the information recorded. Check that each operation is performed and recorded in full compliance with the issued Batch Manufacturing Record and in accordance with the approved procedure. Verify entries made on documents of BMR by counter-checking…
Pharmaceutical Quality Inspection A number of advanced pharmaceutical quality Inspections system to help improve process safety, Pharmaceutical product inspection systems inspect products such as tablets, capsules, powders, or liquids, and pharmaceutical package inspection for products packed in bottles, vials, jars, ampules, blister packs, cartons. Pharmaceutical product inspection systems in the pharmaceutical industry and can be fully…
Interview Question & Answer Pharma QA Process/activity Reference Guideline/method Process validation PV FDA JAN-2011 EMA 2012 Including(ICH Q8, Q10) Blend Uniformity & Content Uniformity (stratified sampling) ISPE (December 2014) ASTME 2709/E2810 USP Chapter No: 905 Friability USP chapter 1216 Disintegration USP chapter 709 Hold Time Study WHO Expert Committee on Specifications for Pharmaceutical Preparations: forty-…
HOLD TIME FOR DISPENSED MATERIAL, INTERMEDIATES, AND FINISHED PRODUCTS PURPOSE The purpose of this SOP is to describe the systematic procedure to establish the hold time of Dispensed materials, intermediate and bulk products prior to final packing SCOPE This SOP is applicable for Dispensed materials, intermediate as well as bulk products that hold time to…
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PREPARATION, CONTROL, ISSUANCE, REVIEW, RETRIEVAL, AND ARCHIVAL OF BATCH MANUFACTURING RECORD AND BATCH PACKING RECORD PURPOSE To lay down a procedure for the preparation, control, issuance, review, retrieval, and archival of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) SCOPE This SOP is applicable to describe the procedure for preparation, control, insurance, review, retrieval…
REPORTING OF DEVIATION All deviations must be reported immediately on the day of discovery, but not later than the end of the next working day, and logged within the same day or the end of the next working day but not later than. Deviation shall be initiated in the following circumstances but not limited to…
Risk Assessment tools used by Pharmaceutical Industry Risk Assessment Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. Quality risk assessments begin with a well-defined problem description or risk question. When the risk in question is well defined, an appropriate risk management tool…
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RECEIPT, STORAGE, AND DISPATCH OF FINISHED GOODS PURPOSE To lay down a procedure for Receipt and storage of Finished Goods from Production and dispatch from warehouse. PROCEDURE RECEIPT AND STORAGE OF FINISHED GOOD All the finished goods received from production to be accompanied by Transfer Ticket Attachment-I. Finished Goods transfer ticket shall be generated through…
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OPENING AND CLOSING OF THE DEPARTMENT PROCEDURE Opening of department Collect the keys from the security gate and enter the detail in register. Switch on the lights located at the entry of the department. Check that the seal on the main door of the department is intact & only then open the department. (If applicable)…
HANDLING OF SPILLAGE/ BREAKAGE OF MATERIAL CONTAINERS IN THE RM STORE PURPOSE To lay down a procedure for handling of spillage/ breakage of material container in RM store. PROCEDURE For Solid Materials If any Spillage/Breakage are occurred, Store person shall segregate or shift other surrounding materials to avoid contamination. Store person shall intimate to QA…
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CLEANING AND OPERATION OF RLAF CLEANING PROCEDURE: At the beginning of the shift (Minor Cleaning) The store person shall ensure that the RLAF power supply is switched off before starting a cleaning Clean the external surface of the RLAF with a vacuum cleaner. Mop the external surfaces with a clean lint-free cloth damped with purified…
OPERATION AND CLEANING OF VACUUM CLEANER Operation of Vacuum Cleaner First, insert the plug of the Vacuum Cleaner in the socket provided in the area. Switch “ON” the main power of the socket as well as the switch provided by a vacuum cleaner. Attached are accessories provided with Vacuum Cleaner as per the requirement of…
HANDLING, CLEANING, AND CALIBRATION OF STANDARD WEIGHT PROCEDURE Handling of weight: Each standard weight shall bear an identification number. Don’t touch the weight directly with bare hands, wear hand Gloves for handling weights. Carefully handle the weight to avoid any mechanical damage All Standard weights shall be stored in a dust-free closed box. Issuance of…
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Vibro Sifter and It working principle The Vibro Sifter works on the principle of gyratory vibrations. The material is separated based on its particle size. Once the motor gets energized, vibration is caused in the screen/sieve making the material travel across the sieves according to its particle size. Highly effective for screening, scalping, de-dusting, and…
Paste Kettle A paste Kettle (starch paste kettle) including a tilting paste kettle is designed for paste preparation. Starch Paste Kettle confirms cGMP norms and comprises a jacketed hemispherical bowl with all necessary steam accessories. The design principle of this kettle is the jacket for passing steam in order to melt down the product to…
Disposal of in-process & rejected products OBJECTIVE: To lay down a procedure to describe the steps to be followed for disposal of in-process samples & rejected products during manufacturing. SCOPE: This SOP covers the disposal of in-process samples / rejected products, manufactured.. RESPONSIBILITY: IPQA and Production personnel shall be responsible to follow the procedure mentioned…
JOB RESPONSIBILITIES OBJECTIVE To lay down the Procedure for preparation of Job Responsibilities. PROCEDURE To maintain a satisfactory system of Quality Assurance and manufacturing of drug products, as per cGMP requirements. Total operation is divided into various functions, called Departments. The following are the departments : Warehouse Production Engineering & Utility Quality Control Quality Assurance…
Corrective and preventive action OBJECTIVE : To lay down a standard procedure for corrective and preventive action(s) system related to product quality/system attributes. PROCEDURE : Definitions: Corrective action: Action is taken to eliminate the root cause of an existing non – conformity, defect, or other undesirable situation in order to prevent a recurrence. Preventive Action:…
Good Documentation Practices OBJECTIVE: To lay down a procedure to describe the steps to be followed for good documentation practices; and ensure that each personnel receives clear and detailed description of the relevant job assignment to minimize the risk of misinterpretation and error. PROCEDURE : Principle: Good Documentation constitutes an essential part of the Quality…
Product Recall OBJECTIVE: To lay down the Procedure for handling Product Recall. PROCEDURE: Recall: Recall means a firm’s removal of products from the market that considers being adverse reaction or in the case of patient safety, a violation of the law. Withdrawal: Withdrawal means a firm’s withdrawal, removal, or correction of a distributed product from…
