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Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
Construction cost management is a fee-based service in which the construction manager (CM) is responsible exclusively to the owner, acting in the owner's interests at every stage of the project. The construction manager offers impartial advice on matters such as: Optimum use of available funds; Control of the scope of the work; Project scheduling
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2]
The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...
Preventive action is any proactive method used to determine potential discrepancies before they occur and to ensure that they do not happen (thereby including, for example, preventive maintenance, management review or other common forms of risk avoidance). Corrective and preventive actions include stages for investigation, action, review, and ...
A contingency plan, or alternate plan, also known colloquially as Plan B, is a plan devised for an outcome other than in the usual (expected) plan. [1] It is often used for risk management for an exceptional risk that, though unlikely, would have catastrophic consequences.
Design–build (or design/build, and abbreviated D–B or D/B accordingly), also known as alternative delivery, [1] is a project delivery system used in the construction industry. It is a method to deliver a project in which the design and construction services are contracted by a single entity known as the design–builder or design–build ...
The concept of retainage is unique to the construction industry and attempts to do two things: provide an incentive to the contractor or subcontractor to complete the project and protect the owner against any liens, claims or defaults, which may surface as the project nears completion. [4]