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 …

Checklist for Precautions during Sample Dilution /preparations in Wet Labs Checklist for Do’s Use a bulb pipette for further dilution. During pipetting Wipe off the tip with clean tissue paper. Adjust the meniscus to eye level by discarding the solution to waste. Transfer the amount to the volumetric flask. Touch the …

Hydrochlorothiazide and its Mechanism of Action Hydrochlorothiazide is a thiazide diuretic used to treat edema associated with a number of conditions, and hypertension. Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. The drug has been widely used to treat hypertension globally and is relatively very safe. Hydrochlorothiazide acts on the …

CEPHALOSPORINS & MECHANISM OF ACTION Cephalosporins are a group of semisynthetic antibiotics derived from ‘cephalosporin-C’ obtained from a fungus Cephalosporium. Cephalosporins are chemically related to penicillins the nucleus consists of a β-lactam ring fused to a dihydrothiazine ring, (7-aminocephalosporanic acid). By the addition of different side chains at position 7 …

SOP On SOP – Initiation of new SOP In Pharma Industry The fundamental purpose of an SOP in pharma is to provide clear and concise instructions for the consistent execution of routine operations within an organization. By offering a step-by-step guide on how tasks should be carried out, SOPs aim …

REGULATORY IMPACT ON OOS Stability study required OOS should be reported to RA OOS batch should not be sold to the Regulatory market OOS batch can not be blended with a fresh approved batch OOS batch can not be directly sold to the market Reporting Test Result Result: Averaging Appropriate …

OOS RECORDING PROCEDURE REPORTING TO THE LABORATORY SUPERVISOR RECORDING AND NUMBERING OF OOS INVESTIGATION BY ANALYST LABORATORY TESTING APPROVAL BY LAB. SUPERVISOR TESTING BY ANALYST PROCEDURE OF OOS INVESTIGATION: A written record of the review should include the following information A clear statement of the reason for the investigation. A …