Pharma Tips

GMP Control of Components and Drug Product Containers and Closures (SUBPART E)

By: Pharma Tips | Views: 3076 | Date: 24-Apr-2011

(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing and approval or 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 all times be handled and stored in a manner to prevent contamination.(c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suit


GENERAL REQUIREMENTS:
(a)    There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing and approval or 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 all times be handled and stored in a manner to prevent contamination.
(c)    Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.
(d)    Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status.

RECEIPT AND STORAGE OF UNTESTED COMPONENTS,
DRUG PRODUCT CONTAINERS, AND CLOSURES:

(a)    Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.
(b)    Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, as appropriate, and released. Storage within the area shall conform to the requirement.


TESTING AND APPROVAL OR REJECTION OF  COMPONENTS, DRUG PRODUCT CONTAINERS, AND CLOSURES:

(a)    Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.

(b)    Representative samples of each shipment of each lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by 211.70

(c)    Samples shall be collected in accordance with the following procedures:

(1)    The containers of components selected shall be cleaned where necessary, by appropriate means.
(2)    The containers shall be opened, sampled, and selected and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures.
(3)    Sterile equipment and aseptic sampling techniques shall be used when necessary.
(4)    If it is necessary to sample a component from the top, middle and bottom of its container, such sample subdivisions shall not be composted for testing.
(5)    Sample containers shall be identified so that the following information can be determined: name of the material sampled, the lot number, the container from which the sample was taken, the date on which the sample was taken, and the name of the person who collected the sample.
(6)    Containers from which samples have been taken shall be marked 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 each component of a drug product. Specific identity tests, if they exist, shall be used.
(2)    Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
(3)    Containers and closures shall be tested for conformance with all appropriate written procedures. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/ closures by the manufacturer and provided that the manufacturer validation of the supplier's test results at appropriate intervals.
(4)    When appropriate, components shall be microscopically examined.
(5)    Each lot of a component, drug product container, or closure that is liable to contamination with filth, insect infestation, or other extraneous adulterant shall be examined against established specifications for such contamination.   
(6)    Each lot of a component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use.

VENDOR CERTIFICATION:
Vendor verification is a system that assures that a supplier's produced under controlled conditions, resulting in consistent quality conformance. Being based on the principle of defect prevention, rather than defect detection and inspection, it significantly reduces the need for customer inspection.
    Vendor certification is a supplier-customer partnership and can only be successful with the full involvement and agreement of both partners.

Customer Teams
    The team will include representatives from manufacturing, package engineering, purchasing and quality assurance with support, as appropriate, from other disciplines such as finance and research and development. The initial task of the team will be to define the objectives and potential benefits and to write a process that can be used as a basis for discussion with suppliers.
Supplier Selections
    The initial selection of potential partners should take into account the supplier's history in terms of quality, delivery, and support service as well as the importance of the specific material to the business. Vendor certification has a higher chance of success with a supplier who already has a high commitment to quality and customer service.
Initial Supplier Contacts
    The proposed process will be discussed with the supplier.

Process Elements

a.    Supplier process. Some or all the customer vendor certification team should visit the supplier's plant to gain an understanding of the production process and the key elements which impact on the achievement of quality standards. Where a material may be supplied from more than on plant of the supplier, each plant must be treated as a separate entity for certification purposes.

b.    Specifications. A detailed review should be made of product specifications with particular reference to legal requirements and fitness for use.

c.    Process evaluation. The supplier must have suitable equipment to monitor the process. This equipment must be routinely calibrated and test methods validated. Statistical process control techniques will usually be applied to demonstrate that the process remained under control, within acceptable operating ranges, throughout each production run. Process control data for several batches, chosen at random, should be reviewed to confirm supplier compliance. Vendors are being requested to demonstrate that their production processes are validated, especially for the manufacture of bulk pharmaceutical chemicals.

Process and Specification Changes:

Vendor certification process is the procedure for handling any changes to the process or the specification. Any proposed changes must be clearly documented, with reasons and supporting data, and be reviewed and accepted by the customer prior to introduction.

A similar procedure should be in place in the event the customer intends to change the specification. Any proposed changes to the customer's process which could impact on the usability or performance of the supplier's material also require prior review and agreement with the supplier.

Customer Inspection
    After it has been confirmed that a supplier has a control process, there usually will be a period when both parties evaluate material quality and compare data. Vendor certification provides a strong basis for the application of reduced testing by the customer. The customer should perform audits of the supplier's process at appropriate intervals. This can be a useful opportunity to review the entire vendor certification process and to evaluate success.

Supplier Reporting
    Vendor certification is a partnership, it is important that both supplier and customer are kept informed of each other's difficulties. The supplier should also provide certificates of compliance or certificates of analysis for every batch-formatted in a manner which is acceptable to the customer. The customer should also provide feedback to the supplier with respect to compliance with specification, performance in use, and delivery service.

Decertification
    Certification results in a high level of reliance on the supplier: reduced incoming inspection, reduced inventories, higher output. Any failure by the supplier can therefore have serious consequences and may require decertification of that supplier for that material.
a.    The tighter specification ranges usually result in higher yields and reduced equipment downtimes for the supplier, thereby providing an opportunity to reduce prices or minimize price increases. A similar situation can occur with the customer and should also result in more consistent product quality.
b.    More consistently compliant batches can result in lower inventories for both supplier and customer. This reduces the cost of carrying inventory.
c.    Reduced testing by the customer eliminates some testing costs but more importantly can make materials available to production more quickly. This allows further inventory reductions and is also of benefit when materials are urgently required for unexpected production.

USE OF APPROVED COMPONENTS, DRUG PRODUCT
CONTAINERS, AND CLOSURES

Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
    Materials management systems now include a need to reevaluate material after a predetermined time and prior to use. This will further minimize the chance that materials in an unsuitable condition will be use.

RETESTING OF APPROVED COMPONENTS, DRUG PRODUCT CONTAINERS, AND CLOSURES

Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the components, drug product container, or closure.

REJECTED COMPONENTS, DRUG PRODUCT CONTAINER, AND CLOSURES
    Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
    FDA investigators frequently use a visit to the reject area as a potential source of deficiencies. If rejections occur it is possible to assume that the vendor process is not adequately under control, and an evaluation of the cause should have been performed and documented.
 

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Dhanya.s  |  28-Jun-2012 00:19:37 IST
sir,
I am Dhanya,a b.pharm graduate.I completed b.pharm with rank.kindly suggest me on job vaccancies.
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