Paper batch records are replaced by an electronic batch recording software. The application provides a complete solution with electronic signatures and audit trails. The electronic batch recording software, includes text, graphics, data, audio, pictorial or other information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.
The master production record is often referred to as the master batch record. This is the documented and approved set of instructions used to describe how to manufacture a specific product. The required elements of the master batch record are outlined in CFR Title 21 Part 211.186.
The master batch record consists of the recipe, which includes the material requirements, equipment, resource requirements, processing instructions, sampling requirements and various notes regarding batch processing. It is the template that is used repeatedly to manufacture a consistent product. Batch record is a journal that documents all events in the batch lifecycle.
The intent of these records is to assure product uniformity from batch to batch. The master production and control records for each product include written procedures for batch formulation that must be followed on the shop floor, and a complete batch control record to document that each significant step in the manufacture, processing, packing, or holding of the batch is done. These records must be signed and dated by at least one individual, and independently checked, dated, and signed by a second person.
The Master Batch Record (MBR) provides detailed recipe-specific information. It is a complete specification for manufacturing a specific batch size in a specific plant at a specific time. The MBR must provide:
• Name and strength of the product with its description
• Name and weight or measure of each active ingredient
• Complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristics
• Accurate statements of the weight or measure of each component, using the same weight system
• Statement concerning any calculated component excesses
• Statement of theoretical weight or measure at appropriate phases of production processing
• Description of product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the individuals responsible for label approval
• Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed
The MBR contains all the key information in the product recipe, including a complete specification to manufacture the product in a given plant, batch size, and date range. The MBR contains the recipe header information, validity rule data, formula details, routing details, instructions, and material dispensing setup information with the corresponding instructions. It is available for viewing and printing after the recipe validity rule is approved for general use.
Batch control records provide a complete information set related to the production and control of each individual batch. The Control Batch Record (CBR) is updated with actual data as the batch proceeds through its lifecycle. Material usage, dispensing activities, and component weights and measure records provide batch traceability. Product output quantities, lot details, manufacturing nonconformance’s, and quality sampling and test results all add to this batch history. The CBR must provide:
• An accurate reproduction of the appropriate MBR checked for accuracy, dated, and signed
• Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:
o Start date, stop date, and time stamps for each step
o Identity of specific major equipment and production lines used
o Identification of each batch of component or in-process material used
o Weights and measures of components used in processing
o In-process and laboratory control results
o Inspection of the packaging and labeling area before and after use
o Complete labeling control records, including specimens or copies of all labeling used
o Description of product containers and closure systems
o Quality sampling performed
o Identification of the individuals who performed each task
o Identification of individuals who supervised or checked each significant step in the operation
o Documentation of any investigations for nonconformance
o Results of examinations made for compliance
The electronic CBR is created when the production batch is created. It is updated with actual data as the batch progresses though its life cycle. The CBR contains information such as actual material usages, product output quantities and lot details, manufacturing nonconformance, quality samples and results, label images, instructions, material dispensing setup information with the corresponding instructions, changes in batch and batch step status, operator comments, and all electronic signatures captured during the processing of the batch.
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