Quality records retention

Production part approvals, tooling records, etc shall be maintained for the length of time that the part is active for production plus one calendar year, unless otherwise specified. This requirement, although removed, is implicit in the new requirement for record retention. However, the note on including purchase orders as quality records is removed, implying that they are not considered quality records but are documents and retained until obsolete. 

Is the retention time for quality records established and recorded ... 

The standard requires the retention times of quality records to be established and recorded. The supplementary requirements extend the records retention requirements to quality system related documents and records to satisfy regulatory and customer requirements as a minimum. 

It is important that records are not destroyed before their useful life is over. There are several factors to consider when determining the retention time for quality records ... 

While the ISO 9001 requirement applies only to quality records, ISO/TS 16949 extends retention times for many other documents because you cannot demonstrate you have or had operations under control without specifications, plans, procedures, etc. You may also need to retain tools, jigs, fixtures, test software - in fact anything that is needed to repair or reproduce equipment in order to honor your long-term commitments. 

You may only need one procedure that covers all the requirements but this is not always practical. The provisions you make for specific quality records should be included in the procedures for controlling the activity being recorded. For example, provisions for inspection records should be included in the inspection procedures, provisions for design review records should be included in the design review procedure. Within such procedures you should provide the forms (or content requirements for the records), the identification, collection/submission provisions, the indexing and filing provisions. It may be more practical to cover the storage, disposal, and retention provisions in separate procedures because they may not be type-dependent. Where each department retains its own records, these provisions may vary and therefore warrant separate procedures. 

Specify retention times for quality records and quality system related documents in the related procedures. 

In which documents do you record the retention times of quality records and quality system documents ... 

Requirements in the areas of facilities, animal care, and personnel were the most often met, while the fewest requirements were met in the areas of the quality assurance unit, mixing and storage of the test substances, and record retention. 

Quality records are identified, established, and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records are legible, readily identifiable, and retrievable for quality records. A procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition. 

The retention time of quality records is according to the record retention policy. 

All quality records are legible and identifiable to the product involved. Quality records are stored and maintained in such a way that they are readily retrievable in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss. Retention times of quality records have been established and recorded. Where agreed contractually, quality records are made available for evaluation by the purchaser (client) or the purchaser s representative for an agreed upon period. 

Description of quality program and change control SOPs commitment to GMP, including record retention that meets FDA requirements... 

Document tracking CRF correction Data entry Data coding Quality control system Computer system, software Data reporting Record keeping Record retention Training initiatives... 

Review quality plans and key validation documents (i.e.. Validation Plan, Requirements, Test Plan, Test Results, Acceptance, Record Retention (Archiving and Change Control)... 

Food and Drug Administration investigators found generally acceptable performance in the archival and record retention areas as well as in the area of the physical facilities associated with animal care and laboratory operations. The lack of findings in these areas is encouraging, as it may be recalled that a major problem that precipitated FDA s concern for the quality and integrity of safety data was in the area of raw data retention. 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

Multiway and particularly three-way analysis of data has become an important subject in chemometrics. This is the result of the development of hyphenated detection methods (such as in combined chromatography-spectrometry) and yields three-way data structures the ways of which are defined by samples, retention times and wavelengths. In multivariate process analysis, three-way data are obtained from various batches, quality measures and times of observation [55]. In image analysis, the three modes are formed by the horizontal and vertical coordinates of the pixels within a frame and the successive frames that have been recorded. In this rapidly developing field one already finds an extensive body of literature and only a brief outline can be given here. For a more comprehensive reading and a discussion of practical applications we refer to the reviews by Geladi [56], Smilde [57] and Henrion [58]. 

Japanese Ministry of Health and Welfare (1997), Regard to Retention of Records by Using Magnetic Media, Concerning Manufacturing Control and Quality Control of Pharmaceutical Products and Medical Devices, Open Letter to Every Prefectural Health Lead Officer, Inspection Guidance Division of Pharmaceutical and Medical Safety Bureau, September 18. 

There are no additional or reduced regulatory requirements for closing sites. Computer systems should be maintained in a validated state of compliance up until the very last day of their operational life. GxP records must be archived and stored for the required retention periods. Archived records should be readily retrievable to support critical quality operations like recall, customer complaints, and batch investigation. Computer systems should then be decommissioned, as discussed later in this chapter. Some computer systems may be disassembled and sent for installation at other sites as part of a program of drug product transfers. 

Electronic records requiring particular regulatory control should be identified based on critical process control points and associated critical parameters that directly impact product quality or product safety. A defined process should be used to conduct this analysis, and it should be one that builds on or is complementary to any assessment conducted as part of product registration. Consistency is key. There may be additional records identified by predicate rules but care must be taken not to extend beyond these records. A risk assessment should be conducted to determine appropriate electroific record management controls such as audit trail and archiving. Electronic records will need to be archived for retention periods specified in predicate rules. Other data related to process performance rather than product quality or product safety requires only basic data maintenance and may be retained for much shorter periods before being purged. 

A part of the analytical planning for a chemical complex is the setting up and maintenance of a sample library, where analyzed samples from each tank car load or reactor lot are stored for reference purposes. The retention time for these samples is set to exceed the probable delay between the time of product shipment and time of final consumption. Thus, if a customer is having difficulty with a particular batch of product, the retained samples enable the company to check the specifications and render rapid technical assistance. Reanalysis of the sample may also be used by the company to accept or reject claims regarding the quality of a product shipment. Thus, proportional process control, raw materials and product, analysis, sample retention, and careful record-keeping all comprise important parts of an operating chemical complex necessary for the maintenance of product quality and customer satisfaction. 

Records should be retained for each delivery. They should include the description of the goods, quality, quantity, supplier, supplier s batch number, the date of receipt, assigned batch number and the expiry date. National regulations which state a period for retention of records must be observed. Where no such regulations exist, records should be retained for one year after the end of the shelf-life of incoming products. 

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