Quality control documentation

Sample requirement and specimen collection Preparation of analytical device— machine and/or consumables Performance of test Performance of quality control Documentation of test result and quality control result Reporting of test result to appropriate personnel Interpretation of result and sources of advice Health and safety issues e.g disposal of sample and test device, cleaning of machine and test area)... 

Suppliers of materials and reagents should be expected to operate according to standards appropriate to their supply and use, and to provide relevant quality control documentation. The developer has the responsibility to confirm that critical materials detailed in the SOP(s) are suitable for their intended purposes. Furthermore, it is important to monitor different batches of materials with regard to changes or variations, which may affect their use. For certain reagents, such as serum, testing prior to use may be necessary. 

Quality control documents for relabelling Drug dispensing log... 

Any Quality Control documentation relating to a batch record should be retained for one year after the expiry date of the batch. 

The general requirements for the preparation of manufacturing and quality control documents are as follows ... 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

Quality Control. Reproducible production of perfumes requires careful quality control of all materials used as well as the compounding process itself. The use of analytical tools has iacreased over the years with their availability, but there can be no substitute for organoleptic evaluation. The human nose is far more sensitive than any analytical instmment for certain materials, yet it is also quite limited as a quantitative tool and is subject to fatigue. There are also weU-documented examples of specific anosmias ia iadividuals, ie, iaability to smell certain odor types, which is somewhat analogous to color-blindness. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

Documentation Data volume includes all quality control forms, e.g., zero/span control charts and multipoint calibration results... 

Combining the practice of preventive maintenance and total quality control and total employee involvement results in an innovative system for equipment maintenance that optimizes effectiveness, eliminates breakdowns, and promotes autonomous operator maintenance through day-to-day activities. This concept known as Total Productive Maintenance (TPM) was conceived by Seiichi Nakajima and is well-documented in his book Introduction of TPM and is highly recommended reading for all involved in the maintenance area. 

As a result of these merits thin layer chromatography finds application all over the world. The frequency of its application is documented in Figure 3. This CA search only includes those publications where TLC/HPTLC are included as key words. The actual application of the method is very much more frequent. The method is employed as a matter of course in many areas of quality control and routine monitoring of product purity. This was also true in the 1970s when the rapid development of high performance liquid chromatography (HPLG) led to a... 

A note in clause 4.2.1 states that all the quality systems documents should be controlled. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

All processes in the production of PSS columns are controlled by an efficient multistep quality control (QC) system (25). This QC system requires complete tests and documentation for all materials used in all production stages. All QC work has to be performed by specially trained and highly skilled polymer chemists. 

To ensure that QC and testing procedures are followed a quality control manual should be implemented. It is a document usually setup in a computer s software program that states and provides the details of the plant s quality objectives and how they will be implemented, documented, and followed. 

Collectively, the combination of appropriate facilities, equipment, documentation, manufacturing practices and quality control procedures provide a basis for effective product and process control. This is illustrated in Figure 11.10. 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

Off-the-shelf catalogue sales of micro reactors have just started [15]. With an increasing number of commercial products, quality control will become more important. Brandner et al. describe quality control for micro heat exchangers/reactors at the Forschungszentrum Karlsruhe [23]. All manufacturing steps are accompanied by quality control and documentation. Leak rates (down to 10 mbar 1 s for He) and overpressure resistance (up to 1000 bar at ambient temperature) are measured. Under standardized conditions, the mean hydraulic diameter is determined. Dynamic tests supplement this quality control. 

If the product is to be used for pharmaceuticals the GMP rules must be obeyed during plant operation. All chemicals to be tested in clinical studies with humans must be prepared according to GMP. This leads to very detailed documentation since if you haven t documented it, you haven t done it . All procedures for manufacturing and changes in procedures are subject to approval by quality control departments. This decreases the flexibility in process development. Products that are contaminated too much must be reprocessed according to the GMP guidelines. All equipment to be used in the pilot plant must be validated before use. 

ISO Guide 33 (1998) deals with other uses of RMs. It elaborates on various uses of RMs, excluding calibration, which is the subject of ISO Guide 32. In most cases, RMs are used as a quality control measure, i.e. to assess the performance of a measurement method. Most matrix RMs are produced with this purpose in mind. Other purposes of RMs are the maintenance of conventional scales, such as the octane number and the pH scale. ISO Guide 33 provides guidance on the proper use of RMs, and therefore it is together with ISO Guide 32 the most important document for users of CRMs. 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

There is an abundance of references defining and describing the role played by QA, Quality Control (QC) and Total Quality Management (TQM) in a modem commercial analytical laboratory. The role played by reference materials (RMs) and certified reference materials (CRMs) in the pursuit of analytical measurement accuracy is also well documented. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

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