Quality Management System Services

  1. Good Manufacturing Practice (GMP)- Traditional Product/ Traditional Medicine

Under the “Control of Drugs and Cosmetics Regulations 1984”, compliance with Good Manufacturing Practice (GMP) is one of the requirement for the evaluation of a Manufacturing License application. Overall control is essential in the manufacture of traditional medicine under strictly controlled and monitored conditions to ensure that the consumer receives medicines of quality, safety and efficacy. The area of control are the starting materials, manufacturing processes, building, equipment and personnel involved.

The manufacture of traditional medicines that utilize materials of natural origin such as plants and animals are prone to contamination, deterioration and variation in quality. Therefore, the control of the starting materials, storage as well as manufacture of traditional medicines is important. It is not sufficient that the finished product merely passes testing protocols but quality must also be built into the product.

In JasCal Management & Consultancy, we are providing the service on GMP consultation to assist our clients in complying with GMP requirements at their manufacturing plants.

2. Good Manufacturing Practice (GMP)- Cosmetic Product

Overall control is essential in the manufacture of cosmetic product under strictly controlled and monitored conditions to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control. The quality of a product depends the starting materials, manufacturing processes, building, equipment and personnel involved.

The control of the starting materials, storage as well as manufacture of cosmetic product is important. It is not sufficient that the finished product merely passes testing protocols but quality must also be built into the product.

In JasCal Management & Consultancy, we are providing the service on GMP consultation to assist our clients in complying with GMP requirements at their manufacturing plants.

3. Good Distribution Practice for Medical Device (GDPMD)

Distribution is an important activity in the supply chain of medical device product. Various people and entities are generally responsible for the product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration etc. All the above mentioned activities need to be appropriately managed and controlled to ensure the safety and performance of medical devices at the point of use.

Therefore, Good Distribution Practice for Medical Devices (GDPMD) provides assurance to stakeholders through certification that the company is able to maintain the quality, safety and performance of medical devices while under its custody. The GDPMD is developed to elucidate the requirements for an appropriate management and control of these activities. GDPMD specifies that a quality management system shall be established, implemented and maintained by a company carrying out activities in the medical Devices Act 2012 (Act 737). It is applicable to all parties involved in the supply-chain of medical devices covering authorized representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia.

The GDPMD certification is to be conducted by the registered conformity assessment body. The design and implementation of GDPMD by a company is dependent on the types and categories and classification of medical device, size and structure of the company, the processes employed it deals with. It is not the intent of the GDPMD to imply uniformity in the structure of the quality management systems or uniformity of documentation.

Certification to GDPMD does not imply compliance to any written laws. It is the responsibility of the company to ensure that they are in compliance with all applicable laws in Malaysia. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.

In JasCal Management & Consultancy, we are providing the service on GDPMD consultation to assist our clients in complying with GDPMD requirements at their companies.