Personnel Hygiene Requirement All employees are advised and encouraged to observe the following guidelines: – [a] To wash hands properly. [b] To keep hair short and clean at all times. Combing hair is strictly prohibited in GMP areas. [c] To keep the nails well-trimmed and cleaned. [d] Not to eat or drink in the manufacturing…
Health Requirements for Personnel Engaged in Production The personnel and Administration department is responsible for maintaining the health requirements of all employees. Pre-employment medical examination All the employees directly or indirectly associated with production activities are undergoes medical examinations before they join the company. A candidate to be employed in manufacturing areas should be free…
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Identification of training needs The training needs of employees are identified by qualification, past experience, personal discussion, and on the basis of day-to-day observation by the respective department heads, with respect to their job responsibility. On the basis of these identified training needs, a complete training program is planned. For all new recruitment, a set…
RESPONSIBILITY OF QUALITY ASSURANCE FUNCTIONS: Quality assurance can be defined as “part of quality management focused on providing confidence that quality requirements will be fulfilled.” The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties. An alternate definition is “all the planned and systematic activities implemented within the quality system…
Vacuum leak test machine To provide a written procedure for cleaning, operation, monitoring & precaution of vacuum leak test machine. Vacuum leak test: A vacuum leak test is the process to detect the weak part of the body or joints in the container by means of a vacuum. This process is carried out in the…
SOP List Small Volume Parenteral General planning and works instruction in production Entry & Exit Procedure for Clean Area Manufacturing Room Entry & Exit Procedure for Clean Area Filling Room Clean & Sanitization of Classified/Clean area Procedure for Packing Material Reconciliation and its Destruction Area cleaning and Sanitization Disinfectant solution preparation, consumption & Destruction for…
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…
