Production Quiz 02

Quiz

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 … Read more

Production Quiz 01

Clean Room Quiz 4

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

Market Complaint -Stages of Handling

Market Complaint -Stages of Handling A market/consumer complaint is a notification that a product is in commercial distribution (which also includes a physician sample). it May be in violation of the laws or regulations administered by the FDA (Drug Control Authority) or May have caused an illness, injury, or death and Is alleged to have … Read more