Text of Control of component, containers and closures
Control of components, containers &closures, production & process control:packaging &labeling controlABDUL MUHEEMM.PHARMA II SEM.(PHARMACEUTICS)
Control of component, containersand closuresSubpart E
INTRODUCTION A draft of GMP regulations was prepared in 1975which was implemented in 1988 in the form ofamended Schedule M. GMPs form the heart of quality GMPs comprises a set of practices that ensuresquality at every level of operation in an industry. GMPs provide quality assurances that off-the-shelf testing cant. GMPs are more immediate and consistent way tocontrol quality.4/26/20133
As per FDA, CFR - Code of Federal RegulationsTitle 21 Part 210 :- Current Good Manufacturing Practice inManufacturing, Processing, Packing and Holding of DrugsPart 211: - GMP for Finished PharmaceuticalsPart 225:- Current GMP for medicated feedsPart 600: BiologicsPart 820: Medical Devices4/26/20134
Subparts of Schedule-MSubpart:A Finished Pharmaceuticals:B Organization and PersonnelC Building and FacilitiesD EquipmentsE Control of Components and Drug ProductContainer and ClosureF Production and Process ControlG Packaging and Labeling ControlH Holding and DistributionI Laboratory ControlJ Records and Report4/26/20135
Section 211.80 General requirements 211.82 Receipt and storage of untestedcomponents, drug product containers, and closures 211.84 Testing and approval or rejection ofcomponents, drug product containers, and closures 211.86 Use of approved components, drug productcontainers, and closures. 211.87 Retesting of approved components, drug productcontainers, and closures. 211.89 Rejected components, drug productcontainers, and closures Drug product containers and closures
211.80 General requirements. (a) There shall be written procedures describing in sufficient detail thereceipt, identification, storage, handling, sampling, testing, and approvalor rejection of components and drug product containers and closures;such written procedures shall be followed. (b) Components and drug product containers and closures shall at alltimes be handled and stored in a manner to prevent contamination. (c) Bagged or boxed components of drug product containers, or closuresshall be stored off the floor and suitably spaced to permit cleaning andinspection. (d) Each container or grouping of containers for components or drugproduct containers, or closures shall be identified with a distinctive code .This code shall be used in recording the disposition of each lot. Each lotshall be appropriately identified as to its status
211.82 Receipt and storage ofuntested components, drug productcontainers, and closuresa) Upon receipt and before acceptance, each container or grouping ofcontainers of components, drug product containers, and closures shallbe examined visually for appropriate labelling as tocontents, container damage or broken seals, and contamination.(b) Components, drug product containers, and closures shall be storedunder quarantine until they have been tested or examined, whicheveris appropriate, and released. Storage within the area shall conform tothe requirements of 211.80.
211.84 Testing and approval orrejection of components, drug productcontainers, and closures(a) Each lot of components, drug product containers, and closuresshall be withheld from use until the lot has beensampled, tested, or examined, as appropriate, and released foruse by the quality control unit.(b) Representative samples of each shipment of each lot shall becollected for testing or examination. The number of containers tobe sampled, and the amount of material to be taken from eachcontainer, shall be based upon appropriate criteria such asstatistical criteria for component variability, confidence levels, anddegree of precision desired, the past quality history of thesupplier, and the quantity needed for analysis and reserve whererequired by 211.170.
(c) Samples shall be collected in accordancewith the following procedures:(1) The containers of components selected shall becleaned when necessary in a manner to preventintroduction of contaminants into the component.(2) The containers shall be opened, sampled, andresealed in a manner designed to prevent contaminationof their contents and contamination of othercomponents, drug product containers, or closures.(3) Sterile equipment and aseptic sampling techniquesshall be used when necessary.
(4) If it is necessary to sample a component from thetop, middle, and bottom of its container, such samplesubdivisions shall not be composited for testing.(5) Sample containers shall be identified so that the followinginformation can be determined: name of the materialsampled, the lot number, the container from which thesample was taken, the date on which the sample wastaken, and the name of the person who collected the sample.(6) Containers from which samples have been taken shall bemarked to show that samples have been removed from them.
(d) Samples shall be examined and tested as follows:(1) At least one test shall be conducted to verify the identity of eachcomponent of a drug product. Specific identity tests, if they exist, shall beused.(2) Each component shall be tested for conformity with all appropriate writtenspecifications for purity, strength, and quality.(3) Containers and closures shall be tested for conformity with all appropriatewritten specifications.(4) When appropriate, components shall be microscopically examined.(5) Each lot of a component, drug product container, or closure that is liableto contamination with filth, insect infestation, or other extraneous adulterantshall be examined against established specifications for such contamination.
(6) Each lot of a component, drug product container, or closure withpotential for microbiological contamination that is objectionable inview of its intended use shall be subjected to microbiological testsbefore use.(e) Any lot of components, drug product containers, or closures thatmeets the appropriate written specifications ofidentity, strength, quality, and purity and related tests underparagraph (d) of this section may be approved and released for use.Any lot of such material that does not meet such specifications shallbe rejected.
211.86 Use of approvedcomponents, drug productcontainers, and closures.Components, drug product containers, and closuresapproved for use shall be rotated so that the oldestapproved stock is used first. Deviation from thisrequirement is permitted if such deviation istemporary and appropriate.
211.87 Retesting of approvedcomponents, drug productcontainers, and closures. Components, drug product containers, and closures shall beretested or re-examined, as appropriate, foridentity, strength, quality, and purity and approved orrejected by the quality control unit in accordance with 211.84 as necessary, e.g., after storage for long periods orafter exposure to air, heat or other conditions that mightadversely affect the component, drug product container, orclosure.
211.89 Rejectedcomponents, drug productcontainers, and closures Rejected components, drug productcontainers, and closures shall be identified andcontrolled under a quarantine system designed toprevent their use in manufacturing or processingoperations for which they are unsuitable.
211.94 Drug productcontainers and closures (a) Drug product containers and closures shall not bereactive, additive, or absorptive so as to alter thesafety, identity, strength, quality, or purity of the drug beyond theofficial or established requirements. (b) Container closure systems shall provide adequate protectionagainst foreseeable external factors in storage and use that can causedeterioration or contamination of the drug product. (c) Drug product containers and closures shall be clean and, whereindicated by the nature of the drug, sterilized and processed toremove pyrogenic properties to assure that they are suitable for theirintended use. Such depyrogenation processes shall be validated. (d) Standards or specifications, methods of testing, and, whereindicated, methods of cleaning, sterilizing, and processing to removepyrogenic properties shall be written and followed for drug productcontainers and closures.
PRODUCTION & PROCESSCONTROL
1. Assure that your companys products are meeting the needs ofcustomers with regard to quality and that company suppliers aremeeting internal company requirements.2. Validate and/or map the current processes for the selectedproducts.3. Evaluate whether the current product and process controls that arein place are able to meet these needs.4. Identify optimized or new Critical to Quality Critical toCustomer requirements for the vital few needs and assure thatan effective process control system control plan is in place forthe s