Quality Control in Pharmaceutical Manufacturing: Solid Dosage Forms PDF

Quality Control in Pharmaceutical Manufacturing: Solid Dosage Forms Quality control (QC) is a critical aspect of pharmaceutical manufacturing, ensuring the safety, efficacy, and consistency of medicinal products. This presentation delves into the specifics of QC procedures for solid dosage forms, fo...

Quality Control in Pharmaceutical Manufacturing: Solid Dosage Forms Quality control (QC) is a critical aspect of pharmaceutical manufacturing, ensuring the safety, efficacy, and consistency of medicinal products. This presentation delves into the specifics of QC procedures for solid dosage forms, focusing on tablets, a prevalent and widely used dosage form in the pharmaceutical industry. Dr Mona Elsayh Understanding Quality Control in Pharmaceutical Manufacturing Quality Assurance (QA) Quality Control (QC) QA encompasses all activities that aim QC ensures the consistency and to prevent product defects. It compliance of manufactured products establishes a system for ensuring to predefined standards. It involves quality throughout the manufacturing sampling, testing, documentation, process. QC is a part of QA, focusing and analysis to identify and address on the direct testing and monitoring any deviations from established of products. specifications. Solid dosage forms 1 Tablets 2 Capsules Made by compressing a mixture of active Consist of a shell that enclose the API and pharmaceutical ingredients and excipients excipients in either a powder or granule they have different forms like buccal form. They are two types :hard shelled ,sublingual , chewable ,enteric coated and capsules (contains powder)and soft shelled effervescent capsules(contains oil). 3 Granules 4 Lozenges 5 Suppository They are dry preparations of a definite They are hard medicines that dissolves Solid dosage form that is applied to the particle size ,comprised of API and suitable slowly within the oral cavity.they are rectum. excipients. designed to prolong the effects of the Suppositories are composed of an active medicine within it’s target site such as ingredient within what’s called suppository antiseptic and anti tussive base. Quality Control of Tablets: A Comprehensive Approach 1 Weight Uniformity 2 Content Uniformity Ensures each tablet contains the correct Determines the accuracy of active dosage of the active ingredient, ingredient content in individual tablets, guaranteeing consistent therapeutic ensuring the intended dosage is efficacy across the batch. consistently delivered. 3 Dissolution 4 Mechanical Strength Evaluates how readily the active ingredient Measures the tablet's hardness and dissolves from the tablet, impacting its resistance to breakage, crucial for bioavailability and effectiveness in the withstanding handling and manufacturing body. processes, ensuring product stability and integrity. Weight Uniformity Test: Ensuring Consistent Dosage 1 Sampling Randomly select 20 tablets from the batch, representing the overall homogeneity of the production run. 2 Individual Weighing Weigh each tablet separately using an analytical balance, ensuring accurate and precise weight measurement. 3 Deviation Calculation Calculate the percentage deviation of each tablet's weight from the average weight of the sample, quantifying the variation within the batch. 4 Acceptance Criteria Compare the deviations to established pharmacopeial limits, ensuring compliance with predefined standards for weight uniformity. Weight Uniformity Test: Aspocid 75 mg 1 Sampling Randomly select 20 tablets from the batch, representing the overall homogeneity of the production run. Calculate individual and average Weighing 2 Average Weight=Sum of Individual Weights​/20 3 Deviation Calculation Deviation (%) = (Individual Weight−Average Weight/Average Weight​) ×100 Weight Uniformity Test: Aspocid 75 mg 4 Acceptance Criteria For tablets weighing 80 mg or less, deviations shouldn’t exceed ±10% 80–250 mg, deviations should not exceed ±7.5%. For tablets >250 mg, deviations shouldn’t exceed ±5% Product complies the test if not more than two tablets deviate from the average weight percentage and none exceeds double the limit. Causes for weight variations: The size and distribution of granules being Poor flow and high-speed turret speed Poor mixing (lubricants and glidants aren’t compressed (presence of too large or too (incomplete filling of the die) distributed properly) fine granules) The variability of lower punches length, so the fil of each die varies because the fill is volumetric. Content Uniformity Test: Method Sampling It’s done for tablets weighting ≤40 mg, to ensure dosage uniformity. Randomly select 30 tablets from the batch, representing the production run's overall content uniformity. Initial Assay Assay the active ingredient content in 10 tablets using a suitable analytical method, determining the average content. Acceptance Criteria Assess the individual tablet content against established limits, ensuring the desired amount of active ingredient is present in each tablet. For 10 individual tabs: The product complies with the test If the content in all tabs falls within 85 % to 115%. If one individual content falls within the range 75% to 125% Further Assay assay the remaining 20 tablets to further evaluate content uniformity within the batch. Dissolution Test: Evaluating Active Ingredient Release Purpose Methodology Acceptance Criteria Assesses how rapidly and completely the Involves immersing tablets in a simulated Determines if the tablet meets predefined active ingredient dissolves from the tablet, gastric fluid at controlled temperatures and dissolution profiles, ensuring the active impacting its absorption and therapeutic stirring speeds, monitoring the release of ingredient dissolves within a specified time effectiveness in the body. the active ingredient over time. frame and to a desired extent. Mechanical Strength: Ensuring Tablet Integrity Hardness Test Friability Test Evaluates the resistance of the tablet to crushing or breakage, Measures the tablet's resistance to abrasion and chipping during ensuring it can withstand handling and packaging processes without handling and transportation, ensuring it maintains its integrity and crumbling. shape. Visual Inspection: Ensuring Tablet Appearance and Uniformity Appearance Checks for any discoloration, defects, or inconsistencies in the tablet's appearance. Shape Verifies the tablet's shape is consistent with specifications and free from any distortions or deformities. Size and Dimensions Measures the tablet's diameter and thickness using a vernier caliper or micrometer, ensuring uniformity within the batch. In-Process Control: Maintaining Quality Throughout Production In-process control involves continuously monitoring and adjusting critical parameters during manufacturing, ensuring the quality of tablets is maintained throughout production. This proactive approach helps minimize deviations and ensure product consistency. Essential Instruments for Quality Control A range of specialized instruments are crucial for conducting various QC tests, ensuring the accuracy, precision, and reliability of results. These include: Analytical Balances Dissolution Apparatus Disintegration Tester Hardness Tester Friability Tester Vernier Caliper or Micrometer UV-Vis Spectrophotometer