In-process Quality Control (IPQC) – PST06103 Pharmaceutical Production
NTA Level 6 • Semester 1 • PST06103 In-process Quality Control (IPQC) Pharmaceutical Production • Source Session/Topic 22 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 22: In-process Quality Control (IPQC) Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Explain the concept of in-process quality control • List tests and equipment/apparatus used for in-process quality control of tablets and capsules • Explain the consequences of in-process quality control of tablets and capsules • List the objectives of in-process quality control Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |25 minutes |Buzzing |The Concept of In-process Quality | | | |Presentation |Control | |3 |20 Minutes |Presentation |Objectives of In-process Quality | | | | |Control | |4 |55 Minutes |Presentation |In-process Quality Control Tests in | | | | |the Manufacture of Tablets and | | | | |Capsules | |5 |05 minutes |Presentation |Key Points | |6 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: The Concept of In-process Quality Control (25 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What is in-process quality control? | | | |ALLOW few pairs to respond and let other pairs to add on points not | |mentioned | | | |WRITE their response on the flip chart/board | | | |CLARIFY and SUMMARIZE by using the content below | • In-process quality control is a type of quality control that provides accurate specific and definite description of procedure to be employed from the receipt of raw material to the release of the finished product • In-process quality control performs checks during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications • In-process quality controls are usually performed within the production area. The performance of such in-process controls should not have any negative effect on the quality of the product or another product • Generally, the in-process control procedures are usually rapid and simple tests or inspections that are performed when the manufacturing of a product batch is in progress STEP 3: Objectives of In-process Quality Control (20 minutes) • Some of the objectives of in-process quality control are; o To minimize human errors o To provide accurate, specific and definite description of the procedure to be employed in manufacturing of a product o To detect errors if and when they occur o To pin point responsibility to the personnel involved in the operation of the entire process o To ensure that the flow of manufacturing and packing operations according to established routes and practice is rigidly followed o To detect abnormality immediately and at the same time indicate action needed to correct the problem STEP 4: In-process Quality Control Tests in the Manufacture of Tablets and Capsules (55 minutes) • Evaluation of dosage forms (tablets); o General appearance ▪ Size, shape and texture ▪ Unique identification markings (embossing, engraving or printing) ▪ Organoleptic properties (e.g. colour distribution, taste, odour) o Content uniformity test ▪ 30 tablets are kept aside (sampled), 10 tablets are assayed, 9 tablets should have percentage limit of 85-115% ▪ If more than 1 tablet has 85-115%, then, 20 tablets are assayed and not more than 1 tablet should have 75-125% o Tablet hardness test or tablet crushing strength ▪ Hardness of a tablet is the force required to break a tablet in a diametric compression test ▪ Hardness testing is a laboratory technique used to test the breaking point and structural integrity of tablet under conditions of storage, transportation, and handling before usage (breaking point of a tablet is based on its shape) ▪ Tablet hardness is tested by using Tablet Hardness Tester e.g. Monstanto hardness tester, Stokes harness tester, Erweka tester, Schleuniger or heberlein tester, Strong Cobb tester and Pfizer hardness tester ▪ Conventional tablet hardness: 2.5 – 5 kg/cm2 ▪ Dispersible/chewable tablet hardness: 2.25 -2.5 kg/cm2 ▪ Extended release tablets hardness: 5-7.5 kg/cm2 o Friability ▪ Friability is the tendency of tablets to powder chip or fragment. This affects the elegant appearance of tablets and consumer acceptance of the tablets ▪ Friability leads to variation in the weight and content of tablets ▪ Friability is related to hardness of a tablet ▪ Instrument used for friability testing is known as Friabilator (e.g. Roche friabilator) ▪ Consisting of a plastic chamber that revolves at 25 rpm dropping the tablets through a distance of 6 inches in the friabilator, which is then operated for 100 revolutions ▪ From the friabilator, the tablets are reweighed ▪ Loss in weight is determined ▪ Allowable range is 0.5 – 1.0% o Weight variation ▪ 20 tablets are taken (sampled) and weighed individually ▪ Average weight of the 20 tablets is determined ▪ Weight of individual tablet is compared to the average weight ▪ Not more than 2 of the individual tablet weights deviate from the average weight by more than the prescribed percentage deviation and none deviates by more than twice that percentage (e.g. USP limits, I. P limits) o Disintegration test ▪ For most tablets, the first important step towards formation of solution is break down of the tablet into smaller particles or granules i.e. disintegration ▪ Disintegration test is performed by use of the disintegration apparatus ▪ The disintegration apparatus is comprised of glasses and a