batch packaging record


Presentation Description

No description available.


Presentation Transcript


BATCH PACKING RECORD By Mrs. Chetna D. Modi Asst. Prof. Skip, Shankhalpur


DOCUMENTATION The document is information (meaningful data) and its supporting medium, which could be in paper form, CD, computer files, or microfilm. Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history . Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance .


PURPOSE OF DOCUMENTATION To define the specifications and procedures for all materials and methods of manufacture and control To ensure that all personnel concerned with manufacturing know what to do and when to do it. To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale. To ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation. And to ensure the availability of the data needed for validation, review, and statistical analysis.




REQUIRED DOCUMENTS Specifications including tests on identity, content, purity and quality for starting and packaging materials and specifications for intermediate, finished , and bulk products. Specifications for water, solvents and reagents (e.g. acids and bases) used in production. Pharmacopoeias, reference standards , and other reference materials A formally authorized master formula s for each product and batch size. Formally authorized packaging instructions for each product, pack size and type. A batch processing record for each batch processed. Before any processing begins, a check should be made and recorded. (equipment is clean and work station are clear) A batch packaging record for each batch or part batch processed. Batch number allocation, e.g. in a log­book. Analysis records, Records should be maintained to facilitate the recall of the batch if necessary. Records should be kept for major and critical equipment of any: Validations and Calibrations Maintenance and repair operations and cleaning Standard operating procedures should be available for: Equipment assembly and validation Analytical apparatus and calibration Maintenance, cleaning, and sanitization Personnel matters including qualification, training, and hygiene Environmental monitoring Pest control and assigning responsibility for cleaning and sanitation Written release and rejection procedures Complaints, Recalls, Returns and Sampling For testing materials and products at different stages of manufacture describing the methods and equipment to be used. For describing the details of the batch (lot) numbering system For the internal labelling , quarantine and storage of starting materials, packaging materials and other materials For the receipt of each delivery of starting material and printed packaging material.


BPR RESPONSIBILITY Executive - Planning. ACCOUNTABILITY Manager -Production Planning and Inventory Control . A Batch Packaging Record should be kept for each batch or part batch processed. It should be based on the relevant parts of the Packaging Instructions and the method of preparation of such records should be designed to avoid transcription errors. The record should carry the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained. Before any packaging operation begins, there should be recorded checks that the equipment and work station are clear of previous products, documents or materials not required for the planned packaging operations, and that equipment is clean and suitable for use.


PACKING INSTRUCTIONS Name of the product; Description of its pharmaceutical form, and strength where applicable; The pack size expressed in terms of the number, weight or volume of the product in the final container; A complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types, with the code or reference number relating to the specifications of each packaging material; Where appropriate, an example or reproduction of the relevant printed packaging materials, and specimens indicating where to apply batch number references, and shelf life of the product; Special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before operations begin; A description of the packaging operation, including any significant subsidiary operations, and equipment to be used; Details of in-process controls with instructions for sampling and acceptance limits.

BPR includes:

BPR includes The name of the product; The date(s) and times of the packaging operations; The name of the responsible person carrying out the packaging operation; The initials of the operators of the different significant steps; Records of checks for identity and conformity with the packaging instructions including the results of in-process controls; Details of the packaging operations carried out, including references to equipment and the packaging lines used; Whenever possible, samples of printed packaging materials used, including specimens of the batch coding, expiry dating and any additional overprinting; Notes on any special problems or unusual events including details, with signed authorisation for any deviation from the manufacturing formula and processing instructions; The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, in order to provide for an adequate reconciliation.

authorStream Live Help