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IPC releases guidance document on Quality Management System in testing laboratory
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Yash Ved, Mumbai
September 25 , 2021
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The Indian Pharmacopoeia Commission (IPC) has released a guidance document on Quality Management System (QMS) in testing laboratory.
QMS consists of documentation of the laboratory policy and objectives, system procedures and instructions for assuring the quality of its results to meet safety and regulatory requirements and to satisfy the needs of the customers.
The document said that a pharmaceutical laboratory which is developing framework for the QMS must establish, document, implement, and maintain a QMS appropriate to the scope of its activities, including the type, range and volume of testing.
Implementation of the QMS by testing laboratories is considered as the best approach to achieve these goals and attain accreditation status for their services leading to the validity of the test results.
Pharmaceutical laboratories carry out tests and assays for the confirmation of active pharmaceutical ingredients, pharmaceutical products and excipients to meet predefined specifications and thus play an important role in clinical or public health setting, the document stated.
"For there to be an effective QMS, organizational structure capable of supporting the elements of the quality policy and quality objectives, as well as responsibilities and tasks of both management and technical staff should be defined. The organizational structure should be such that departments having conflicting interests do not adversely influence the laboratory’s work quality. Also, the organization should take into account applicable regulatory requirements, the size of the laboratory, the complexity of materials and products, and other critical activities when developing the QMS structure," the document said.
The document stated that the establishment of the QMS is primarily driven by proper documentation of laboratory policies, processes and procedures. Documentation is the mechanism for defining the quality system so that there is a consistent and secure basis for monitoring the system.
The document stated, “Audits are a valuable tool for evaluating QMS effectiveness, along with regulatory inspections. Audits may be distinguished as internal and external audits. Internal audits are conducted by or on behalf of the organization itself and verify that the laboratory complies with the standard.”
Internal audits are an excellent preparation for external assessments and help to continually improve the quality system, while external audits (also known as external assessments) are performed by independent external organizations.
Management review is usually conducted once a year to identify any potential sources of nonconformity or other opportunities for improvement in the QMS or technical operations.
The document stated that pharmaceutical laboratory must establish and maintain procedures to control and review all documents (internally generated and from external sources) that form part of the quality documentation. Document control is a mechanism by which the QMS documents are created, amended, reviewed, approved, distributed and archived.
The mandate of the Commission is to perform, inter-alia, functions such as revision and publication of the Indian Pharmacopoeia and National Formulary of India on a regular basis besides providing IP Reference Substances and training to the stakeholders on pharmacopoeial issues.
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