Documentation manufacturing processing

Relieving the capacity planning problem led to "closed-loop MRP." In closed-loop MRP, the computer calculates the effect of the production plan on work centers. One now knows which centers have the most demand and can take action. Examples of this action can include rescheduling, adding capacity, or contracting out production. Closed-loop MRP requires the organization to fully document manufacturing processes, particularly the bottlenecks. 

Systems depend on accurate data to produce high-quality outputs. For example, the schedule for a poorly documented manufacturing process will have... 

Documentation, manufacturing process instructions (MPIs) See Manufacturing process instructions (MPIs). 

The primary thmst of GMP is that it is not enough merely to make chemicals to meet USP or other apphcable specifications. The chemicals must be made under clean and sanitary conditions, procedures and processes must be vahdated and documented, and processing and packaging must be carried out under conditions that preclude mixup and mislabeling. Records must be kept of complaints, and the manufacturer must know enough about the storage properties of the products to specify storage conditions and, if necessary, expiration dates on the label. 

In March of 1998, the FDA announced a draft guidance document for Industry for the manufacturing, process, or holding of APIs [64]. We shall apply our interpreta-... 

Collectively, the combination of appropriate facilities, equipment, documentation, manufacturing practices and quality control procedures provide a basis for effective product and process control. This is illustrated in Figure 11.10. 

Chromatographic methods of all types have demonstrated utility in package control. Studies on senso-rially and toxicologically important residues have shown that contact of polymers with such substances in the normal manufacturing process results in measurable sorption or retention, even under the extremes of commercial conditions used for their removal. Methodology developed for the determination of such residues is documented and in wide use [23],... 

Process validation is intended to show and document that the process described, when operating within the designated parameters, will produce product of the appropriate quality and demonstrate that the manufacturing process is under full control. Process validation should extend from laboratory-scale and preformulation studies (say to of production scale) to formulation to pilot-scale manufacture (say production scale) to full industrial-scale manufacture, with a clear, logical, and continuous path between these stages. The magnitude of scale-up at each stage should not normally exceed a factor of 10. 

FIGURE 2.1 Iron and steel manufacturing process overview. (From U.S. EPA, Development Document for the Proposed Effluent Limitations Guidelines and Standards for the Iron and Steel Manufacturing Point Source Category, EPA-821-B-00-011, U.S. EPA, Washington, DC, 2000.)... 

Release reporting. Manufacturing businesses with ten or more employees that manufactured, processed, or otherwise used a listed toxic chemical in excess of the established threshold must file annually a Toxic Chemical Release form with U.S. EPA and the state. Documentation supporting release estimates must be kept for three years. 

ELISAs can be used for identification and quantitation of a biopharmaceutical product or for quantitation of impurities or contaminants as discussed previously. They can be used throughout the manufacturing process as well as in quality control or the product release stage just as they are used in all the other stages of product development. To be used for quality control, GMP practices must be followed. All methods need to be validated so that the assay s performance is documented. ELISAs should have internal quality controls to monitor assay... 

Part II Part II is the report concerning chemical, pharmaceutical, and biological documentation. The report details the composition, method of development of formulation, manufacturing processes under GMP, analytical test procedures, bioavailability, and bioequivalence. It should be noted that all analytical test procedures need to be validated, and the validation studies must be provided. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control, and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records. 

This previous definition had been broadened after the FDA s issue of the PAT guidance document to encompass aU factors influencing the quality and efficiency of a chemical or pharmaceutical manufacturing process. Driven by developments in Six-Sigma and operational excellence programs an extended definition included such items as ... 

A comprehensive training program for all employees is another essential element to secure adequate quality and safety standards. The program has to incorporate the entire workforce involved into any aspect of the manufacturing process and needs to be documented. 

Quality control and assurance Final product must be made under current good manufacturing process (cGMP)— emphasis placed on the final bulk product The product is the manufacturing process —cGMPs from seed stock or first step onward evaluated with equal scrutiny Regulated under analytical procedures and method validation, chemistry, manufacturing and control (CMC) documentation... 

Manufacturing process modification Document manufacturing changes in annual reports Approval required for every manufacturing change before implementation Submit manufacturing changes and vahdation documents to FDA 30 days prior to product distribution"... 

As a part of its requirements, the FDA demands documentation of manufacturing process controls, which include checks and tests that are performed at each step,... 

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