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 …

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. …

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 …

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 …

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 …

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 …

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 …

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, …

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 …

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 …

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 …

ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR) This Annual product Quality review should be conducted with the objective of verifying the repeatability of existing processes, the appropriateness of current specifications for raw materials and finished products, identifying any trends and identifying any improvements to products and processes. It …

Quality inspection (Self-inspections & Benefits of Self Inspection) Principle Importance and Benefits of Self Inspection What is needed Scope How can self-inspection be conducted Inspection Techniques Example of Self-Inspection Plan Who should be involved Self-inspection report Points to consider when performing self-inspection Stages of Self-Inspection Advantages & Disadvantages of Checklist …

PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS PURPOSE :To describe the procedure for equipment / facility qualification: prepare qualification protocols, to initiate, conduct, and document equipment / facility qualification studies. SCOPE : This SOP shall be applicable to all new and upgraded process related equipment /facility. REFERENCE(S) :ISPE, Volume …

Autonomous Disinfection Solution there is a new technological solution that has emerged in recent years to help combat the spread of disease in public spaces: autonomous disinfection robots. These robots are capable of cleaning and disinfecting public areas without human intervention, making them an ideal solution for high-traffic areas where …

Pseudoephedrine & Mechanism of Action Pseudoephedrine temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and nasal congestion associated with sinusitis. Pseudoephedrine also temporarily relieves sinus congestion and pressure. Drug Class: Nasal Decongestant MECHANISM OF ACTION Pseudoephedrine is a sympathomimetic drug belonging to the phenethylamine and amphetamine chemical classes. Its principal mechanism of …

Checklist for Do’s and Don’ts for Dissolution Analysis Checklist for Do’s Always check the availability of chemicals and required glassware for the analysis. Before loading dissolution check the Calibration status of the instrument. Always check the water level of the dissolution bath (without a bowl). Check the clarity of the water …

Checklist for Do’s and Don’ts for Using Glassware for Analysis Checklist for Do’s Use Class A Glassware for analysis Use  transparent glassware for analysis Before using glassware for analysis check for cracks or breakage. Use exact capacity glassware by checking the marking of capacity e.g. ‘20’ flask not to be used …

Checklist for Do’s and Don’ts for Sample preparation of temperature / light-sensitive material and product Checklist for Do’s In the case of temperature-sensitive / light-sensitive material collect samples from the respective storage area & allowed them to attain room temperature before using i.e weighing, pipetting, etc. During analysis close the sample …

DO’s & DON’Ts For Column care to avoid/Minimize incidences 1.0 New HPLC Columns(Except Silica Columns for Normal Phase) DO’s Before using the new column wash the column with water followed by an appropriate solvent mixture. For Silica Column for washing use solvent as Given in the Column Certificate. DON’Ts Don’t …