Total Quality Management Practices Total Quality Management Practices (TQMS) the first thing that comes to mind when you think of the word “quality”? The word “quality” has many definitions. Quality can be defined as a characteristic or characteristic, as in the following statement: “They are honest people, and that is a good quality.” They also ask…
HANDLING AND INVESTIGATION OF INCIDENTS Incidents – Any unforeseen event or deviations from approved protocols or standard operating procedures without prior authorization and documentation. Any variance from established specifications or requirements stated in Quality System document, which includes but not limited to SOP (Standard Operating Procedure), BMR (Batch Manufacturing Record) and BPR (Batch Packing Record),…
QUALIFICATION STUDY FOR VISUAL INSPECTOR To establish documented evidence that Visual Qualification Protocol is capable to qualify the visual inspector, within the specified quality attributes thereby establishing the Visual Inspectors qualification procedure. Detect and remove units of drug product with predefined defects in a reproducible manner in a controlled process. Each final container of all…
ENVIRONMENTAL MONITOR To ensures clean and sterile conditions for compounding and preparing pharmaceutical products. Sterile compounding pharmacy environments and other cleanrooms can demonstrate compliance standards for monitoring and controlling airborne particles. ACPH. Manufacturing & storage rooms require at least 20 air changes per hour (ACPH) nonsterile area. Buffer rooms and interlock with access. Temperature. Cleanroom…
QUALIFICATION PROTOCOL FOR AIR COMPRESSOR SYSTEM Air compressor system -The purpose of carrying out Qualification of Air compressor system is to establish the documented evidence that the system performance is in accordance with the predefined specifications. The scope of this protocol is to describe the procedure for different tests, acceptance criteria, Re-validation criteria and documentation to be…
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Orbital welding Orbital welding-The pipe or tube to be welded is held while the welding arc rotates (in “orbit”) around the workpiece. Welding parameters are set by a microprocessor, so settings can be saved and reused, ensuring a highly reproducible process. Orbital welding is the automatic or mechanized welding of pipes and tubes using an…
CLEANING AND OPERATION OF VIBRO SIFTER
Change Control Quiz Question: What is change control in the pharmaceutical industry, and why is it considered a critical part of quality management? Answer: Change control in the pharmaceutical industry is a systematic approach to managing product, process, or system changes. It is considered a critical part of quality management because it ensures that changes…
Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry dates to the finished products manufactured. Scope This procedure shall apply to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry dates to batches of finished product Head,…
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SELF-INSPECTION PROGRAMME SELF-INSPECTION / INTERNAL AUDIT is basically a method of an objective overall review of one’s own operation on aspects that may have on quality effect on quality assurance.
Preparation, Approval and Control of Specifications and Standard Test Procedures Objective To lay down a procedure for the preparation, approval and control of Specifications and Standard Test Procedures for raw materials, packaging materials, in-process materials and finished products. Scope This Standard Operating Procedure is applicable for the preparation and implementation of all Specifications and Standard…
Preparation, Approval, Review, and Control of Technical Directions for the Manufacture of Drug Products Objective To lay down a procedure for the Preparation, Approval, Review, and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for the preparation and implementation of Technical Directions for all products manufactured at…
Production Quiz 03 Question: What is capping in the context of tablet manufacturing? Answer: Capping occurs when the upper or lower segment of a tablet separates horizontally, either partially or completely, from the main body of the tablet during ejection from the tablet press or subsequent handling. Question: What is the typical reason behind capping…
ROLE OF QUALITY ASSURANCE The quality assurance department shall be involved in all quality-related matters. The quality assurance department shall posses following responsibility but not limited to the same.
Operation, cleaning & calibration of pH meter 1.0 PURPOSE: To lay down the procedure for operation & calibration of pH meter. 2.0. SCOPE : This SOP shall be applicable for operation & calibration of pH meter of SVP manufacturing facility Equipment Name Make & Model No. Equipment ID pH meter 3.0 REFERENCE(S) & ATTACHMENT(S):…
CLEANING, OPERATION, MONITORING & PRECAUTIONS OF MANUAL VISUAL INSPECTION TABLE & PROCESS FOR MANUAL INSPECTION OF SVP CONTAINERS. 1.0 PURPOSE To lay down the procedure for cleaning, operation, monitoring & precautions of visual Inspection table & process for manual visual inspection of filled & sealed SVP containers. 2.0 SCOPE This SOP is applicable for…
Cleanroom behavior & personal hygiene 1.0 PURPOSE: To describe the procedure for personal hygiene & behavioral approach during clean room operation. 2.0. SCOPE : This SOP will be applicable for behavioral approach & personal hygiene for all the Staff, operators & workers of clean area of SVP section 3.0 REFERENCE(S) & ATTACHMENTS…
Clean area footwear cleaning & sanitization 1.0 PURPOSE: To lay down the procedure for clean area foot ware cleaning & sanitization. 2.0 SCOPE : This SOP is applicable for foot ware cleaning & sanitization for clean area of SVP section 3.0 REFERENCE(S) & ATTACHMENTS: 3.1 References 3.1.1 In-House 3.2 Attachments 3.2.1 Attachment: I…
Entry & Exit procedure for Clean Area Filling Room 1.0 PURPOSE: To provide the written procedure for entry & exit for clean area Filing room. 2.0. SCOPE : This SOP will be applicable for authorized staff & visitor’s movement in clean area filling of SVP section. 3.0 REFERENCE(S) & ATTACHMENTS: 3.1 References 3.1.1 …
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CIP & SIP OF MANUFACTURING TANK, HOLDING TANK,PRODUCT LINE, FILTER ASSEMBLY & FFS MACHINE 1.0 PURPOSE To establish the procedure for CIP & SIP of manufacturing tanks, holding tank, Product line, filter assembly & FFS machine. 2.0 SCOPE This SOP is applicable for CIP & SIP of manufacturing tanks, holding tank, FFS machine &…
