( two ) Attachment to assorted criterions
-Good Manufacturing Practice ( GMP ) , e.g. the 5P’s ( Premise, Primary stuffs, Personnel/People, Procedure, and Process, define and record )
-Standard runing processs ( SOP )
( three ) Quality control ( QC ) and quality confidence ( QA ) of tablets
( four ) Problems occurred during industry of tablets, and solutions ( if any )
( V ) Other treatments ( e.g. certification, audit, R & A ; D, if applicable )
In Malaysia, one of the requirement for using a fabrication licence and merchandise enrollment is the conformity to the Good Manufacturing Practice1. The makers of the registered pharmaceutical/traditional merchandises should adhere to the guideline stated in Good Manufacturing Practice ( GMP ) to guarantee that the merchandise manufactured is safe, efficacious and up-to stated quality. The Good Manufacturing Practice ( GMP ) reviews of makers of registered merchandises are done by Centre for Compliance and Licensing ( CCL ) to guarantee makers conformity towards the current GMP demands.
However, WHO has formulated GMP as a general guideline with rules for states to adhere with2. Some regional demands, such as Pharmaceutical Inspection Convention ( PIC ) , Association of South-East Asia Nations ( ASEAN ) —GMP and European Economic Community ( EEC ) are applied.
The first component to be discussed in GMP is Personnel. The pilot works has equal figure of forces with the necessary makings and practical experience3. Organisation chart with specific responsibilities recorded in written occupation descriptions have to be provided, although in this instance seems to be non available. In footings of preparation wise, preparation is provided to the forces whose responsibilities require them to be in the production country or the research labs. If in any instance, such as untrained forces or visitants should be given briefing about personal hygiene and set in protective vesture in progress before come ining the production room. Other than that, they should be closely supervised every bit good. Protective garments appropriate to the operations are worn by every individual come ining the fabrication country. Prohibition on feeding, imbibing, masticating or smoke is purely adhered. In specific, direct contact should be avoided between the operator ‘s custodies and the open merchandise every bit good as with any portion of the equipment that comes into contact with the merchandises. Hence, gloves must be worn at all times.
The 2nd component included is the Premises and Equipment. Generally speech production, premises and equipment must be located, designed, constructed, adapted and maintained to accommodate the operations to be carried out3. Attempts to understate the hazard of mistakes and license effectual cleansing and care in order to cut down cross-contamination, accretion of dust or soil must be shown through the layout and design of the production works. Repair and care operations should non endanger the quality of merchandises and must be disinfected harmonizing to detailed written processs. The premiss is organised to let the production countries connected in a logical order matching to the sequence of the operations. The interior surfaces, such as walls, floors and ceilings are smooth and free from clefts. The floor trim is curved, to let easy and effectual cleansing. The production country is good ventilated, with air control installations such as HEPA filters to avoid dusting and cut down entrance of dust from external infinites. The deliberation of get downing stuffs is carried out in a separate deliberation room designed for that usage, as stated in the GMP guideline. Excess stairss are taken to avoid cross-contamination in state of affairs where dust is generated, such as in production of tablets, by holding separated closed suites. The packaging of medicative merchandises, in this instance, the tablets, are specifically designed and laid out to avoid confusions. In-process controls are carried out in the production country every bit long as they do non transport any hazard for the production. The pulverizations are observed during granulation procedure. In this pilot works, the storage country is in sufficient capacity to let storage of assorted classs of stuffs and merchandises in orderly mode. Receiving bay ( same country as material room ) protect stuffs from the conditions. It is besides equipped with vacuity cleaning public-service corporation to let containers of incoming stuffs to be cleaned before storage. It is of import to take note that within the pilot works no washroom is available. As stated in the Pharmaceutical Inspection Co-operation Scheme ( PIC/S ) GMP Guide, point 3.31 – lavatories should non straight communicate with production or storage countries, hence, this pilot works complied with the guideline prescribed. Manufacturing equipment should be designed in a manner that eases the cleansing procedure. It should be cleaned harmonizing to detailed and written processs. The installing of equipment should prioritise to cut down the hazard of mistake or of taint. This is the ground most equipment is located following to each other, in a closed country, and contained in the equipment during the transportation. Equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such trials are recorded besides.
The 3rd component is the Documentation. There is a figure of needed GMP certification, for illustration Site Master File, Specifications that describe the demands with which the merchandises or stuffs used or obtained have to conform, Manufacturing Formulae, Processing, Packaging and Testing Instructions, Procedures, Protocols and etc3. In the site, Standard Operating Procedures ( SOPs ) are provided in each processing room, depicting the operating stairss for equipment. Specifications for get downing, packaging, intermediate and bulk merchandises are available for critical stairss. In elaborate, the specifications should include the designated name, Paracetamol in this instance, mention to any pharmacopoeial monograph, approved providers of the stuff, waies for trying and proving, qualitative and quantitative demands with credence bounds, storage conditions and safeguards and in conclusion, the maximal period of storage before re-examination.
The Forth facet in this treatment is Production. Defined processs for production operations must be followed as following with the GMP is necessary to obtain merchandises of needed quality. Other than managing stuffs in right mode, different merchandises must non be carried out at the same time in the same room3. Coevals of dust must be prevented, in this instance, for illustration, by holding dusting bags in the fluidized bed drier. In order to forestall cross-contamination in term of production, appropriate proficient or organizational steps are taken. Air-locks are installed and closed system of production is used. Lone stuffs that are validated with recorded consequences are used.
The 5th component is the Quality Control. Quality control comprises trying, specifications and testing of the merchandises. It is of import to stress that Quality Control is independent from Production. Quality Control besides requires the necessary and relevant trials are being carried out3. Several testing is conducted in conformity to USP specifications, such as weight fluctuation, hardness, crumbliness, disintegration and etc. Other than the trials mentioned, the proper certification and release processs which maps to account that the trials are being carried out, quality control besides comprise of all determinations which may impact the quality of the merchandise. However, it is of import for to take note that for a complete finished merchandise appraisal, all the relevant factors have to be taken into history, such as production conditions, consequences of in-process testing, a reappraisal of fabricating certification, conformity with Finished Product Specification and scrutiny of the concluding finished battalion. All relevant certification should be made available to the Quality Control for measuring the quality of the merchandise. A batch record has to be kept at least a twelvemonth after the termination day of the month of the batch. The method of trying should adhere to O.K. written processs such as equipment to be used and the sum of sample to be taken, type and status of sample container and storage conditions. Mention samples from each batch should be retained until one twelvemonth after the termination day of the month and the sample size should be sufficient to let at least a full re-examination. The cogency of proving methods should be confirmed and harmonizing to approved methods. Consistency of consequences should be checked. The readying of research lab reagents, glasswork, solutions, mention criterions and civilization media should be harmonizing to written processs. Marketed merchandise should be monitored for its stableness.
- National Pharmaceutical Control Bureau, Ministry of Health Malaysia. Good Fabrication Practice/Good Distribution [ Online ] . 2013 May 14 [ cited 2015 Feb 5 ] ; Available from:Uniform resource locator:hypertext transfer protocol: //portal.bpfk.gov.my/index.cfm? & A ; menuid=146 & A ; parentid=113
- Jaya Bir Karmacharya. Good Fabrication Practices ( GMP ) for Medicinal Products [ Online ] 2012 May 23 [ cited 2015 Feb 5 ] ; Available from:Uniform resource locator:hypertext transfer protocol: //cdn.intechopen.com/pdfs-wm/37170.pdf
- Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme. Guide To Good Manufacturing Practice For Medicinal Products Part I [ On-line ] . 2014 Mar 1 [ cited 2015 Feb 5 ] ; Available from:Uniform resource locator:hypertext transfer protocol: //www.picscheme.org/publication.php? download & A ; file=cGUtMDA5LTExLWdtcC1ndWlkZS1wYXJ0LWktYmFzaWMtcmVxdWlyZW1lbnRzLWZvci1tZWRpY2luYWwtcHJvZHVjdHMtY29weTEucGRm