Reference standards receipt/documentation

Reference Standard and Critical Reagents Source records should document lot numbers, date of receipt or preparation (as appropriate), the identity, purity, and stability at the time of use, expiration date (as applicable), storage location (e.g., equipment identifiers), and temperature conditions. 

Each container of reference standard should be labeled by name or Chemical Abstracts (CA) number, log or batch number (as provided by the supplier), expiration or reassay date (if any) and storage conditions necessary to maintain the identity, strength, purity and composition of the reference standard. Observations related to receipt of shipped materials and any unresolved discrepancies should be documented. AU shipment papers such as bUls of lading and express shipment forms should be retained and stored with the rest of the project or study data. 

Documentation of preparation of stock and sub-stock solutions must start with receipt of the reference standard, its Certificate of Analysis, assigned purity (and possibly chiral purity) and its history of storage and use after receipt (Section 9.4.4). Procedures for preparation and subsequent dilution of stock solutions are described in Section 9.5.4 and stability testing for these solutions in Section 10.4.Ih. Some of the relevant documentation might be included in general laboratory SOPs but full documentation of all study-specific procedures and data regarding preparation, storage and validation of stock solutions is required. 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

Written instructions and procedures must be prepared to control and document the receipt of equipment, supplies, and services that affect the quality of measurement. Examples are reference materials (e.g., radionuclide standards), reagents, supplies (e.g., graduated cylinders, pipettes, planchets), and computer software and hardware. Controls should ensure that only correct items are accepted. If specifications are not met or the material is otherwise unsuitable, the QA officer should be notified and the material returned. 

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