Package documentation

Once the class boundaries are defined, it is important to determine whether any of the classes in the training set overlap. This indicates the discriminating power of the SIMCA models and will impact the confidence that can be placed on future predictions. TTiere are various algorithmic measures of class overlap and the reader is referred to their software package documentation for details. In this chapter, class overlap is indicated when training set samples are predicted to be members of multiple classes. This is demonstrated in a two-dimensional example shown in Figure 4.59- Two classes are shown where class A is described by one principal component and class B is described by two principal components. The overlap of the classes is indicated because unknown Z is classified as belonging to both classes. 

Although it is the responsibility of an excipient user to qualify their excipient suppliers, that burden is shared with the distributor as well. A pharmaceutical distributor must provide the user with the assurance that the excipients supplied are unadulterated, have not been tampered with, and are free from contamination. To ensure this, a distributor must have warehouse and internal controls in place, comply with current regulatory standards, and should be an active NACD member. Trace-ability of ingredients is another critical need that must be met by pharmaceutical distributors. This can be achieved by providing the manufacturer s original packaging, documentation, and manufacturing site address, confirmed by the manufacturer. 

Standard off-the-shelf software packages—document version, verify operation... 

The tender package documentation needs to provide all the elements necessary to define the project, and typically includes the project validation plan, a detailed scope of work, the URS, the documentation deliverables, and the associated commercial documentation. 

Any revisions that have been agreed upon by the pharmaceutical manufacturer and the selected supplier must be included in the tender package documents and quotation. Any revisions to the URS must be implemented under the pharmaceutical manufacturer s change control procedure. 

Review and accept software package documentation. IQ — check version installed. 

Key Validation Package Documentation Document Reference Acceptance Criteria Satisfied (Yes/No)... 

Schmidt MW (1997) GAMESS Quantum Chemistry Program Package Documentation (ISU Quantum Chemistry Group ISUQCG, Ames Laboratory — USDOE, Iowa State University, IA 50011 USA)... 

The conclusion and recommendation should be incorporated into the batch manufacturing and batch packaging documents and/or standard operating procedures (SOPs) for routine use. Limits and frequencies of testing and monitoring should be specified. Actions to be taken in the event of the limits being exceeded should be specified. 

When quantities of the label are requisitioned against the packaging documentation, (based on the packaging specification) they should first be visually identified, counted and code checked (preferably by machine reading) and then signed off by the authorised store issuer. The materials are then securely held away from the packaging line area, awaiting use. 

Assessment of finished products should embrace all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack. 

Finished product assessment this should cover, in addition to the bulk product assessment, all relevant factors, including packaging conditions, the result of in-process testing, a review of packaging documentation and compliance with the product specification file and the order. 

A reconciliation should then be made, using prepared spaces on the packaging documents, between the numbers of items issued for packaging (including additional issues if any) and the numbers accounted for. The latter should include, as appropriate, the number used on sound or defective product, on samples, and on cartons, the number returned to store, and the numbers to be destroyed or defaced. 

A Basic Packaging Document, approved and dated by the persons responsible for production and quality assurance, must exist for each end product. This condition can also be met by storing the data in other documents such as manuals or in a computer memory. 

The Basic Packaging Document must contain at least the following data or a reference thereto ... 

The Lot Packaging Record must be derived from the effective Basic Packaging Document and carry the lot and/or packaging number. 

Each Lot Packaging Record must finally be signed by the production manager as proof that apart from any recorded deviations, packaging was performed entirely according to the effective Basic Packaging Document... 

Packaging operations must follow dearly defined written procedures in order to produce finished products of the requisite quality and must comply with their authorised packaging documents as well as all legal requirements. Special attention must be paid to labels and labelling throughout the entire packaging cycle. 

Before a packaging operation begins, checks should be made to ensure that the work area and equipment are clean and free from any product, product residues, materials, labels or documents not required for that operation. The record of these checks should form part of the batch packaging documentation. (Ref. 3.36). 

Test plans document the planned scope of the verification. The test cases are based on developers and quality management team members expertise. Test packages document the implementation of the tests. 

In the design phase of the package, documents should be prepared to define how the requirements of para. 501 are fully complied with for each manufactured packaging. Each document required should be authorized (e.g. signed) by the persons directly responsible for each stage of manufacture. Specific values should be recorded, even when within tolerance. The completed documents should be retained on file in conformance with quality assurance requirements (see para. 310). 

Does it matter if the package documentation is poor Or if the package is unproven or obsolete Or if the users have to cope with two different systems Of course Each of these factors, as well as the functionality, is critical to the success of your new system. So write them down as the criteria against which you will evaluate each package. 

Ease of conversion Vendor support and training Package documentation Audit trail... 

---