Quarantine areas

The customer is responsible for the product they supply wherever it came from in the first place. It is therefore very important that you establish the condition of the product before you store it or use it. In the event that you detect that the product is damaged, defective, or incomplete, you should place it in a quarantine area and report the condition to the customer. Even if the product is needed urgently and can still be used, you should obtain the agreement of your customer before using inferior product, otherwise you may be held liable for the consequences. 

Provide a quarantine area to place nonconforming product pending disposition. 

The standard requires the supplier to provide for the segregation (when practical) of nonconforming product and that quarantine areas have visual identification. 

Provide quarantine areas in which to place articles pending disposition action. 

Prepare procedures for controlling these quarantine areas. 

Also, the facilities and sampling equipment should be sufficient to prevent cross contamination by other materials, products, and general environmental contaminates. Where possible, the sampling should be done in a quarantined area separate from other materials, especially, those that have already passed inspection. For rejected materials, procedures and facilities, i.e., storage space, to handle these materials should be in place. 

Less automated systems that need manual input to confirm that an activity has been completed require data entry to be contemporaneous. If this were not the case, an inspector might walk, for instance, round an available stock area of the warehouse, notice an unattended pallet on a floor in the picking area which is available for picking, and ask someone to show him where this pallet should be. If an enquiry is made into the system that shows that the pallet should be in a separate quarantined area, as outlined in a current SOP, then staff should expect to discuss this further with the inspector. 

Details of normal GMP (perhaps specific to that particular industry) should be highlighted, such as machine layout and space floor and wall conditions segregation and separation of material in storage, work or awaiting use level of lighting material and work identification quarantine areas etc. 

The company GMP system covering work practices throughout the plant and warehouse, e.g. in-company audits, line clean down procedures, material identification and segregation, quarantine areas, general traceability. 

Clear flow paths from raw to finished materials with hold and quarantine areas. 

Materials and finished goods to be identified by name, batch number, date, etc., and to pass through a hold or quarantine area (while under inspection) to a clearly defined storage area when status is confirmed. 

Free stacking of pallets is viable if the warehouse has a low roof and the goods do not occupy space for long periods of time, e.g. a QC quarantine area. 

It is essential in all cases to have quarantine areas, in which quarantine identified incoming goods and finished goods can be held pending QC release. The computer system must reflect the situation in the warehouse by locking out any movement documentation until QC release is obtained. 

Except where an acceptable alternative system is installed, there should be separate storage areas, designated as quarantine areas, for each of the categories of goods shown in Table 139.1. 

Containers of material should not be removed from a quarantine area unless released for use by Quality Control and unless they bear a RELEASED or APPROVED or REJECTED label cancelling the HOLD or QUARANTINE section of the original quarantine label. 

Goods whose release has expired should be labelled as quarantined and promptly returned to a quarantine area. A system of drawing attention to the existence of expired release should be established. 

Materials which have been rejected upon examination, after testing, after re-testing or for any other reason should be identified with a REJECT label. These rejected materials should be segregated, stored in a designated reject quarantine area and returned to the supplier, destroyed or otherwise disposed of without undue delay. Records should be maintained of their disposal. Where the reason for rejection is failure to meet specifications, a note of the rejection should appear on the analytical summary record. 

Where physical quarantine areas are used, they are well marked with access restricted to authorized personnel. Where electronic quarantine is used, electronic access is restricted to authorized personnel. 

They must be intact, labelled containers bearing clear identification, and stored in a special area termed the Quarantine Area. ... 

Written procedures must describe the transfer of finished product into the quarantine area storage while awaiting approval, requirements that must be met for approval and subsequent transfer to the finished goods warehouse. 

Pending release by the quality control unit, the entire packaged lot should be detailed in the finished goods quarantine area. 

Physical access to the quarantine area should be restricted, and only those persons actually required to work in the area or who have been properly authorized to enter the area should be allowed access. 

After the Quality Control unit has approved a batch, the material should be moved from the finished goods quarantine area to finished goods storage. 

If the identity or condition of any container of raw materials or packaging materials is suspicious or does not comply with the requirements of identity or conditions, that container should be delivered to the quarantine area. The quality control unit shall then determine the disposition of the material. 

After recording, the receiving unit should deliver the products to the quarantine area. 

Where a separate quarantine area is provided, access should be restricted to authorized persons. 

K. The product i.s llien renuived to a quarantine area until it is proven ilint no residual gas can be detected. 

When materials are received to be used in the manufacture of a pharmaceutical product, an inspection (and possible testing) is usually necessary before the materials are accepted. Materials may be stored in a separate quarantined area until they are released and approved for use. The use of certified suppliers has allowed some materials to be received and accepted without additional inspection or testing. The certified supplier may provide a certificate of analysis dociimenting that the material meets the required specifications. Certified suppliers are usually audited to insure that they meet the requirements for certification of the customer. 

The operating organization should provide adequate facilities for receiving on the site all materials, spare parts and components for items important to safety. The receiving area should include equipment for safe, convenient handling, and sufficient space with appropriate environmental conditions for proper inspection of items upon receipt. A separate and secure quarantine area should be provided for the temporary retention of stocks not cleared for final storage or issue. 

Facdities should be designedand operated forthe comfort of the animals and the convenience ofthe investigator. Another critical factor in facility design operations involves the prevention of transmission of latent diseases from animal to animal, or animals to humans. The first step involves purchaseofanimals from clean sources who have a documented animal health quality assurance program. Newly arrived animals should be held in a quarantine area in the facility to prevent potential contamination ofexisting research animalpopulations. The quarantine facility should be located in an area adjacent to the main colony, but with separate access to prevent cross-contamination of the colony as would be the case with common traffic flows. 

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