Blog - Good Manufacturing Practice in Indian context

Unlocking Excellence: Laboratory Accreditation and ISO 17025 Compliance for Reliable Testing and Calibration

This is the first of the series of posts regarding the ISO 17025 and accreditation. ISO 17025 specifies the management and technical requirement to be met by testing and calibration laboratories. Accreditation of the laboratories is usually performed by national accreditation bodies which usually has Mutual Recognition Agreements between other national bodies. The accreditation will have the credibility only if the operation of the accreditation body (national body) complies with ISO 17011 and applies the ISO 17025 rigorously on laboratories. The credibility of the laboratory depends on the quality management system which is implemented through the quality manual of the laboratory. It is ironic that the credibility is not dependent on the state of the art instruments or the analyst with years of years of education and training but on the quality system of the laboratory and the quality assurance manager who implements the system. However in most of the laboratories the quality assurance manger is not a qualified personnel and frequently is a mid level manager or the senor-level analyst who performs the quality assurance job as part of his duties. In some instances, these jobs may be contracted out. These situations create the inconsistencies in the policy due to the lack of formalized procedure and differences in writing style. Developing quality manual that is appropriate for the laboratory and its implementation is necessary for achieving the quality. Quality leads to accreditation and accreditation did not lead to quality.

A Look at the Evolution of Quality throughout History

Quality in preindustrial societies

Throughout human history, the concept of quality has been ever-evolving. Hunter-gatherers employed primitive quality techniques to identify which food was safe to consume. When they organized themselves as families, the tasks were divided between members in an efficient manner with excellent co-ordination. People then organized themselves in villages and divided their works which resulted in certain specialized skills and trades, such as farming and fishing. People in these trades were knowledgeable about their tools and processes. They would take their goods to the marketplace and make face-to-face sales with customers. The customers would use their senses to judge the quality. Caveat emptor (“let the buyer beware”) was the basis of trade. This made sense as the buyer and seller usually resided in the same village and the buyer could assess the quality of the items before purchase. If the quality of the product was poor, the producer’s reputation and livelihood was at risk.

Quality Improvement Projects – Getting the Top Managements Approval

Quality improvement projects are a great way to improve the quality of an organization’s products and services. Quality management during the period from 1980s to 1990s shows that the involvement of the upper management in quality projects plays a vital role in the quality improvement. To gain top management approval for quality improvement projects, it is important to present a clear and compelling case. This blog explains some key points in getting the approval for these types of initiatives from the top management.

Clinical Performance Evaluation for new In Vitro Diagnostic Medical Device

The permission to conduct clinical performance evaluation for new in vitro diagnostic medical device can be obtained by a sponsor on submitting an application in Form MD-24 to the Central Licensing Authority, along with a fee prescribed in the Second Schedule and the required documents. If the application complies with the statutory requirements, then the Central Licensing Authority will grant the permission in Form MD-25 or else, the application will be rejected within 90 days from the date of application, after giving an opportunity for explanation. No fee is required if the institute, organisation, hospital is run or funded by the Central Government or the State Government. In public interest, the Central Licensing Authority has the authority to abbreviate, defer, or waive the requirement of clinical performance evaluation.

Clinical Study of Medical Devices

Medical Device Rules 2017 are framed to ensure the credibility of clinical data and the protection of human subjects. Clinical study should be conducted in accordance with good clinical practice guidelines issued by the CDSCO with the protocol approved by the registered ethics committee and performed on subjects from whom the informed consent is obtained.

Procedure to obtain permission to conduct Clinical Investigation of Medical Device

Medical Devices (Amendment) Rules, 2020

The Medical Devices (Amendment) Rules, 2020, was effective from 01st April 2020. Introduction of a new chapter namely, Chapter IIIA, which deals with the registration of medical devices, and the modification of Eight Schedule, were the major amendments made to the existing rules. A major modification in the definition of the Medical devices was also effective from 01st April 2020. You can read more about the modified definition here. This modification in the definition of medical devices brings a host of new devices under the ambit of Medical Devices (Amendment) Rules, 2020.

Medical Device – Modified Definition

On 11th February, 2020, the Ministry of Health and Family Welfare, Govt. of India published a gazette notification namely S.O. 648(E), which puts the definition of medical devices on par with the definitions of rest of the world. This notification is effective from 01st April 2020. You can go through the earlier definition here. In the earlier definition, the onus of determining whether a device is a medical device rests on the Govt. of India i.e. “Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act”. This particular part was now modified, and the same was provided below:

Labeling of Medical Devices from the standpoint of GMP / QMS

Labeling includes all labels and any written, printed or graphic matter on the device or container or wrappers or anything accompanying such device. Label control and labeling content are the two main aspects of labeling. Label mix-ups, product mix-ups, label printing errors, label versus container errors, wrong inserts or outserts are the most common labeling mistakes.

Labeling of medical devices – Medical Devices Rules 2017

Labeling regulations promulgated for the medical devices under Medical Devices Rules 2017, are found in Chapter VI from Rules 44 to Rules 48. Label is defined as the display of written, printed or graphic matter upon the immediate container of any article. Labeling is the broader term that includes the label and the descriptive and informational literature that accompanies the device. It includes equipment labels, control labels, package labels, instruction for use, maintenance manuals, technical description, intended purpose and proper use of the medical device. Labeling helps to identify a device and its manufacturer and it acts as a way to communicate the information related to its safety, efficacy and use. The intended user may be professional or lay persons and relevant third parties.

Import of Medical Devices for Test or Clinical Investigations

The application for import of any medical device or in vitro diagnostic medical device for the purpose of clinical investigations, test, evaluation, examination, demonstration or training shall be made in Form MD-16 to the Central Licensing Authority along with a fee as specified in the Second Schedule. The Central Licensing Authority may grant a test licence in Form MD-17 along with the quantity, or may reject the application within 30 days. The licence is valid for three years.