Records, batch

Production and service provision - Operate production and service provision under controlled conditions, maintain batch records, validation processes that cannct be verified, maintain identification and traceability of materials, address specific requirements for sterile products, provide suitable conditions for storage and distribution... 

Subcase bl This case is encountered, for example, when batch records from different production campaigns are compared and the same number of samples was analyzed in each campaign. (Note under GMP, trend analysis has to be performed regularly to stop a process from slowly, over many batches, drifting into a situation where each parameter on its own is within specifications, but collectively there is the risk of sudden, global loss of control. Catastrophe theory has gained a foothold in physical and biological literature to describe such situations cf. Section 4.14.)... 

Bakshi and Stephanopoulos (1994b) have applied the above procedure to a fed-batch fermentation process. The problem involved 41 sets of batch records on 24 measured variables. Of these variables only very few were found by the decision tree to be relevant, and yield rules such as the following for guiding the diagnosis or control of a fermentor. 

ZRMs for fabricated foods could be easily manufactured following recommendations for development of in-house RM (Craft and Boyer 1993). Batch records, published information, and so on allow the analysts to quickly determine the compositional makeup of fabricated foods and thus to formulate and make a ZRM devoid of a specific micronutrient. 

Retrospective validation uses historical information gathered in actual process runs to evaluate the process. For example, batch records can provide extensive data on column performance and analytical data of fractions and final product can provide valuable information on the efficiency of the chromatographic steps in removing contaminants. Chapman67 cautions that while retrospective validation is a valid and valuable approach, it is not meant to be retroactive — validation must be done before product is released to market. 

Manufacturing Processes Flow charts for production steps, controls for contamination, removal of impurities, purification steps, in-process tests, and batch records... 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

Records include materials transfer records, batch records, materials/inter-mediates/finished product test records, shipping records, water test records, and environmental test records. They provide an audit trail for reviewing all the information related to the production of any batch of drug product. The data are required to be reviewed for product release. 

Materials, processes, and control parameters for drug production are stated in written documents. Production personnel follow procedures and record materials used, amounts weighed, and date of operation. Equipment, reaction vessels, and the production area are cleaned and their status recorded in logbooks. Throughout the production stages, equipment conditions (e.g., pH, pressure, stirring speed, and temperature) are also recorded. Adjustments to in-process control parameters, if permitted, are entered onto batch records. 

Approved batch records must be kept for registering all relevant information during the manufacturing process. 

Production System This includes manufacturing processes, sampling and testing, batch records, and process validation. 

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. 

Exposed ordinary combustibles (Class A) should not be permitted to accumulate in the control room area. Process data printouts, batch records, shipping documents, and other paper in the open should be minimized, preferably limited to one-day s output. Where longer-term storage of such paper files or storage of supplies is required, closed-door metal cabinets should be provided. Metal file cabinets should be provided to store drawings, electrical diagrams, manuals, equipment catalogs, etc. 

Continuous monitoring of certain production processes is necessary, e.g. fermentation. Such data should form part of the batch record. 

Documents that contain confidential information (e.g., laboratory journals, batch records, campaign reports), have to be earmarked and signed at regular intervals by the project manager. The latter surveys the circulation and copying. 

Calloff orders Batch records Compliance with laws and... 

Do not carry batch record and support documents in pockets or to the lockers. 

Identification of the process to be simulated and a copy of the batch record to be used... 

Review the process reproducibility and the batch records for process variations. 

FDA guidance The completed batch record supplied with the chemistry, manufacturing, and controls section of the application should identify the validated processes to be used for sterilization and depyrogenation of any container-closure components. This information may be included in the batch record by reference to the validation protocol or SOP. 

ABC Pharmaceutical Industries information. The equipment preparation pages of the master batch record specify the validated sterilization processes to be employed in the preparation of the equipment for (product name) USP. Cycle sterilization parameters are defined along with attributes such as loading patterns and the mechanics of operating the sterilizing equipment. The following lists the sterilization cycles utilized for the equipment required in the processing of (provide product name) USP ... 

The equipment sterilization charts are included in the batch production record. The equipment sterilization charts for stability batch are produced in support of this submission. These sterilization charts shall be reviewed by Quality Assurance for adherence to the sterilization cycles specified in the batch records. 

Media fill units are treated in the same manner as product and require batch record documentation. All aseptically assembled products manufactured subsequent to a media fill failure are placed in quarantine until acceptable media fill results are obtained. 

QA will review the batch record and make the final summary report. 

The materials and equipment used for manufacturing this batch will be documented in the batch record. 

Due to this principle, a batch B defined for quality control purposes consists of a fixed number of n mini batches (subunits), i.e., B=nb.Thus, a tight in-process control of the mixing/granulation (6-9) and drying step (14) provides an excellent batch record of the quasi-continuous production of granules and an excellent opportunity for a continuous validation of the process and the equipment (14-18,32-34). 

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