Records written procedure

Any deviation from the written procedures shall be recorded and justified. 

To facilitate the maintenance of equipment with different performance criteria, written procedures are needed that serve as a record of the process used to evaluate the system s performance. Maintenance by appropriately trained personnel should be performed at regular intervals before equipment parts fail. 

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

Records are considered as a special type of documents and shall therefore be identifiable and properly controlled. The system for their storage, protection, retrieval, and for their retention time and disposition is documented in written procedures. The laboratory records provide objective evidence of conformity to requirements and of the effective operation of the QMS. 

Written procedures and practices must be in place within the laboratory to verify the accuracy of manually entered and electronically transferred data collected on automated systems. The primary documentation for data entry requirements is an audit trail. Laboratories must ensure that an audit trail exists and is maintained. This audit trail must indicate date and time stamps for each record transmitted and the source instrument for each entry. 

Drug product production and control records are not certified by the quality control unit to assure compliance with all established, approved written procedures before a batch is released or distributed. 

To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed. 

Manufacturing instructions are the written procedures that personnel follow during actual product batch preparation. The instructions must document the modular equipment and materials to be used as well as the unit operations to be performed. (See Figs. 3 and 4.) The master document should also include step-by-step manufacturing instructions as well as GMP-required elements previously listed under the section on batch records. 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

Minimize risk to system design, development, operation, and maintenance by conducting and recording these activities to approved written procedures... 

All inspection, measuring or test equipment, whether mechanical, electrical, automatic, or mechanical in operation, which performs a quality assurance function must be validated for its intended use. This equipment must also be routinely calibrated according to a written procedure and the records that document these activities must be maintained. 

The preparation of master production and control records shall be described in a written procedure. 

Proper production process execution and performance of analytical procedures relies on comprehensive, clearly stated, and unambiguous documentation. This is necessary whether the document is used to initiate an activity (e.g., process, method, work instruction) or contains results that will be reviewed by someone else. A master batch record that can be easily misinterpreted by trained operators is a serious source of process variability. Similarly, if the analytical method is not written in a clear, concise, and sufficiently detailed manner, interpretation may be different from analyst to analyst, also resulting in higher than expected variability and perhaps an OOS result. Process and analytical documentation should be written with the user in mind and authored by individuals with intimate familiarity with the task to be carried out. The written procedures should be concise or crisp, yet contain sufficient technical detail to lead trained operators and analysts through the same set of operations with the outcome being the same when applied to the same material(s). 

The purpose of this regulation is to provide a reliable system for a manufactures to review the quality standards for each drug product it makes. Every manufacture must customize and establish its own written procedures in order to comply with this mandate for annual evaluations of drug products. It has recently become acceptable for a firm to review a representative number of batches in lieu of examining all records for every batch of a manufactured product. Essentially, FDA requires the annual review of a representative number of batches, whether approved or rejected, along with any corresponding QC records associated with those batches. The stated purpose for this requirement is that firms periodically review an... 

Institutional review boards must maintain written procedures of all operations. All activities associated with the following operations must be recorded ... 

The data and concepts developed from research are useless to the records keeper unless they are translated into action. Examples of this action are a written procedure that can be used in the conservation laboratory and a specification that describes a product to be purchased for use in restoration. Some standards in the form of specifications for paper, laminating film, and photographic film are available. Standard procedures, developed in cooperation with a recognized U.S. standards organization for use in conservation laboratories, are not available. 

There are no records to document that the Information Technology (IT) service provider staff persormel have received training that includes current good manufacturing practice regulations and written procedures referred by the regulations. [FDA 483, 2000]... 

Reprocessing can be defined as the repeating of a defined step or sequence of steps outlined in a master production and control record, in order to achieve a predetermined endpoint. Written procedures should be established and followed for any reprocessing steps or operations that are incorporated into a developed manufacturing process. The effectiveness of any reprocessing activity should be demonstrated through validation studies and should be fully supported by data. 

The first type of complaint may be caused by problems such as faulty manufacture, product defects or deterioration as well as, particular to herbal medicines, adulteration of the herbal material. These complaints should be recorded in detail and the causes thoroughly investigated (e.g. by comparison with the reference samples kept from the same batch). There should also be written procedures to describe the action to be taken. 

All entities in the supply chain should be traceable as applicable, depending on the type of product, and on the national policies and legislation. There should be written procedures and records to ensure traceability of the products distributed. 

Stringent precautions should be taken to ensure that rejected materials and pharmaceutical products cannot be used. Rejected goods should be clearly marked as such and stored separately from other materials and pharmaceutical products in a locked compound accessible only to authorized and trained responsible personnel, while the materials await destruction or return to the supplier. Whatever action is taken should be approved by authorized personnel and recorded. Rejected materials should be handled in accordance with a written procedure. 

Recalled materials should be handled in accordance with a written procedure. Written records of all major actions with the signatures of the person responsible for carrying out each action should be maintained. 

Returned goods should be handled in accordance with a written procedure. They should be placed in quarantine imtil a decision has been taken on their fate. Products returned from the market should be destroyed unless it is certain that their quality is satisfactory. In that case, they may be considered for resale. The nature of the product, any special storage requirements, its condition and history, and the time elapsed since it was issued should all be taken into account in this assessment. Where any doubt arises over the quality of the product, it should not be considered suitable for reissue or reuse, although basic chemical reprocessing to recover the active ingredient may be possible. Any action taken should be recorded. 

As previously mentioned, QAU records of findings and problems and of corrective actions recommended and taken are exempt from routine the FDA inspection. To compensate for this lack of routine inspectional authority, the FDA has access to the QAU s written procedures. The FDA may review QAU written procedures to judge the adequacy of inspection schedules and to determine whether or not systems are in place for communicating inspection findings to management personnel. The FDA may also request facility... 

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