SOP for CLEANING AND OPERATION OF VIBRO SIFTER
CLEANING AND OPERATION OF VIBRO SIFTER
Tag: Copenhagen
Change Control Quiz
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…
Production Quiz 03
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…
Stability (ICH Q1A) Quiz 7
Stability (ICH) Quiz 7 Q: What are the requirements regarding the number of primary batches for formal stability studies of a drug substance? A: Formal stability studies necessitate data from at least three primary batches of the drug substance. Q: What criteria must the primary batches meet for inclusion in formal stability studies? A: The…
Stability (ICH Q1A) Quiz 1
Stability (ICH Q1A) Quiz 1 Q: What is the purpose of the revised ICH Q1A guideline mentioned in the text? A: The purpose of the revised guideline, based on the ICH Q1A guideline, is to establish the stability data package necessary for the registration application of a new drug substance or drug product across the…
Production Quiz 02
Production Quiz 02 Question: What is mottling, and what factors contribute to this defect in tablets? Answer: Mottling is a tablet defect that can be caused by colored drugs (Excipient-related), improper mixing of granular material (Process-related), dirt in the granular material, or the use of oily lubricant, leading to oil spots. Answer: How does the…
Production Quiz 01
Production Quiz 01 Question: What are the challenges faced in tablet manufacturing? Answer: The challenges in tablet manufacturing include visual and functional defects, which have increased due to complexities in tablet presses and higher quality demands. Question: Why have advancements and innovations in tablet manufacture not decreased the production problems? Answer: The production problems have…
Operation cum performance qualification protocol cum report
Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description FBD Machine Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency (if any) and Corrective Action…
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Performance qualification protocol cum report
Performance qualification protocol cum report shall consist of minimum contents but not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and Corrective Action Report Acceptance criteria…
Cleaning in Place or CIP systems
Cleaning in Place or CIP systems CIP systems -The cleaning and sanitary aspects of manufacturing drug products are of extreme importance. The pharmaceutical industry must meet high hygienic standards to avoid a product’s degradation and contamination during manufacturing & packing and Area cleaning must be carried out quickly and thoroughly. The cleaning requirements are best met…
Sanitizing the clean rooms
Sanitizing the clean rooms PURPOSE: To lay down the procedure for sanitizing the clean rooms in normal operation and during various interruptions to make the clean area free from microbial & particle load. RESPONSIBILITY: Concern Department Person For the preparation of the Sanitization Solution. Production Person To ensure the sanitization process. To Maintain the record. Production…
Operation & time verification of digital clock
Operation & time verification of digital clock Digital Clock: A digital clock is a type of clock that displays the time digitally (i.e. in numerals or other symbols) as opposed to an analogue clock. Digital clocks are often associated with electronic drives but the “digital” description refers only to the display, not to the drive…
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The compressed air system in Pharma
The compressed air system in Pharma The Moisture free Compressed Air system comprises of state-of-the-art Vertical single cylinder reciprocating air-cooled compressor with a “V” Belt arrangement, starter cum control panel, safety devices, interconnecting piping, cabling, etc. and accessories duly mounted on a rigid steel deck. These packages are provided with anti-vibration mountings to reduce the…
HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT
HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT PRODUCT Complaint: A market/consumer complaint is a notification that a product is in commercial distribution (which also includes a physician sample), May be in violation of the laws or regulations administered by the FDA (Drug Control Authority), May have caused an illness, injury or death, Is alleged to have…
Working Principle of Auto Coater Machine
Working Principle of Auto Coater Machine The film to be coated on the tablet is in liquid form before the process is started so the liquid is filled in the solution tank. The liquid is stirred well in the solution tank and then pumped into the coating pan. The coating pan is perforated and holds…
QUALITY BY DESIGN AND SCALE – UP
QUALITY BY DESIGN AND SCALE – UP Unit operations are the individual basic steps in a process that when linked together define the process train and result in the final product. In practice, a unit operation is defined as an individual step that is carried out on one piece of equipment. In biopharmaceutical API unit…
Retrospective Validation
Retrospective Validation The retrospective validation – to establish manufacturing procedures for products that are considered stable and resource limitations, prospective validation programs cannot be possible. Before initiation of retrospective validation, the numerical in-process and end-product test data of historic production batches are considered for statistical analysis, and the equipment, facilities, and subsystems used in connection…
Reprocessing of non-confirming products (Formulation)
Reprocessing of non-confirming products (Formulation) To establish a procedure for Reprocessing non-confirming products (formulation). SCOPE: This SOP is applicable to all sections of the formulation. RESPONSIBILITY: Department in charge – Implementation of SOP & Documentation. Quality Assurance Person – To verify & monitor the activities as per SOP. R&D Person – Clearance from R&D aspects. ACCOUNTABILITY: Production HEAD PROCEDURE:…
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Accident Management
Accident Management To establish procedures to be followed at the time of any accident during production operation. RESPONSIBILITY: Department in charge –Implementation of SOP & Documentation. Production Supervisor (Present at the time of the accident) – To take the necessary action as per SOP. S&E Person – Clearance from S&E aspects. ACCOUNTABILITY: Production HEAD PROCEDURE: Generally following types of…
Quality Excellence & Quality Culture Check
Quality Excellence & Quality Culture Check Addressing the sources of variability and defects is critically important when the failure rate is excessive or warranty obligations hurt profitability. The Quality Excellence Program helps business leaders, quality managers, and functional specialists to systematically improve process capability and consistently meet customer requirements at the lowest non-performance cost. Quality is defined by…