General quality system requirements

There are a number of quality systems that may be encountered by the pharmaceutical analyst but by and large the major one will be good manufacturing practice (GMP). Compliance to GMP is a requirement for the manufacture and testing of a drug product or API destined for human use, whether in the context 

Before discussing the various quality systems encountered by the pharmaceutical analyst, I would like to more clearly define some of the quality terms that are used to ensure some consistency, as these definitions may vary depending on the quality system. These definitions are taken from the GMP guide for API, ICH Q7A [3] as there is a good chance that more than one interested group has input into the definition. 

Quality control (QC) Checking or testing that specifications are met. 

Quality assurance (QA) The sum total of the organised arrangements made with the objective of ensuring that all materials are of the quality required for their intended use and that quality systems are maintained. 

Quality unit An organisational unit, independent of production, which fiilfils both QA and QC responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending on the size and structure of the organisation. 

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QS 9000—Quality management system requirements cooperatively developed and adopted by the Big Three automobile manufacturers, Chrysler, Ford, and General Motors, along with certain truck manufacturers. QS-9000 incorporates all of the main elements of the ISO 9001 standard and describes the minimum quality system requirements to emphasize continuous improvements, defect prevention, consistency, and elimination of waste. 

QS-9000 shorthand name for Quality System Requirements QS-9000. It is the common supplier quality standard for Chrysler Corporation, Ford Motor Company, and General Motors Corporation. 

ISO Guide 62 1996 General requirements for bodies operating assessment and certification/registration of quality systems... 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

This process uses propylene carbonate as a physical solvent to remove CO2 and H2S. Propylene carbonate also removes C2+ hydrocarbons, COS, SO2, CS2, and H2O from the natural gas stream. Thus, in one step the natural gas can be sweetened and dehydrated to pipeline quality. In general, this process is used for bulk removal of CO2 and is not used to treat to less than 3% CO2, as may be required for pipeline quality gas. The system requires special design features, larger absorbers, and higher circulation rates to obtain pipeline quality and usually is not economically applicable for these outlet requirements. 

The pull system requires that the suppliers to the component fabricator, the component fabricator, and the fabricator s customers work closely together. This is essential as there is little room for error that causes costly line down situations for the fabricators customer. The trend is also for each part of the chain, supplier, fabricator, and customer, to take responsibility for the quality and performance of their own products. This has resulted in a term in general use today, self-certified supplier. ... 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

General Requirements (Implement quality system and continually improve it)... 

General requirements - Implement and maintain a quality system... 

Whereas ISO Guide 34 sets requirements for the quality system of a GRM producer, ISO Guide 35 (1989) provides guidance on how to implement many of these requirements. Among these, the document also provides a general and statistical outline of the process that leads to CRMs. The current edition of ISO Guide 35 is a little outdated, but stiU most of the contents are valid. 

ISO Guide 34 (1996) Quality system guidehnes for the production of reference materials. (Revised March 1998 as ISO/REMCO document No 464 General requirements for the competence of reference material producers . The revised Guide 34 will appear early 2000.) International Organization for Standardization, Geneva. 

The International Standard, ISO 9001 2000, Quality Management Systems -Requirements, is a general standard that applies to all types of organizations,... 

This chapter will focus on those additional GMP requirements for the manufacture of excipient ingredients under an ISO 9001 compliant quality system. While certification to ISO 9001 is unnecessary for compliance to excipient GMPs, many of the manufacturing-related requirements as noted above are essential for adequate GMP conformance. With the numerous ISO 9001 compliance resources available, this chapter will assume the reader has the knowledge to implement those relevant general ISO 9001 requirements. 

It is in the interest of (company name) to ensure that a management system describing its total operations is carefully thought out and implemented so that the likelihood of error is reduced. This can only be achieved by implementing a quality system specific to the company s requirements or the standard, which has global recognition in general. 

Because the NELAC standards are general, they require interpretation or clarification in certain areas of application. That is why the US DOD undertook a task of specifying some of these broad areas in definite terms in a manual that unifies laboratory requirements of the Navy, Air Force, and United States Army Corps of Engineers (DOD, 2000). This manual, titled Department of Defense Quality Systems Manual for Environmental Laboratories, is offered to the DOD representatives and contractors who design, implement, and oversee contracts with environmental laboratories. Currently, the three DOD branches implement their own laboratory accreditation programs with some reciprocity between the three a task force has been created to combine these programs into a single DOD accreditation process. 

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