Good Distribution Practice for Medical Devices (GDPMD)
Scope and Overview of GDPMD
The current regulations in Pakistan require manufacturers to hold ISO 13485 certification, and dealers and wholesalers' GDPMD certification.
GDPMD is largely based on ISO 13485. In fact, aside from added definitions and specific sections addressing disposal of devices, adulterated devices, outsourced activities, and secondary assembly, much of GDPMD is a reduced-scope or reworded version of ISO 13485. As with ISO 13485, ISO 9001 certification cannot be accepted as equivalent to GDPMD.
A Comparative Analysis against ISO 13485:2003 Methodology
This comparison goes through ISO 13485 section by section and highlights the key differences in point forms, followed by brief discussions. Word-by-word differences that are deemed minor are not discussed, or we describe them as basically unchanged.
In general, ISO 13485 consists of eight title sections and two informative annexes;
GDPMD consists of 14 title sections and three normative annexes (see Table below)
This comparison goes through ISO 13485 section by section and highlights the key differences in point forms, followed by brief discussions. Word-by-word differences that are deemed minor are not discussed, or we describe them as basically unchanged.
In general, ISO 13485 consists of eight title sections and two informative annexes;
GDPMD consists of 14 title sections and three normative annexes (see Table below)
Scope, Background, Application Key differences:
- As with ISO 13485, GDPMD allows the organization to justify not implementing a requirement that is deemed not applicable to the medical device(s) in question.
- GDPMD removed the paragraphs relating to design and development controls, and outsourcing (“…processes…which are not performed by the organization…”).
- GDPMD added new paragraphs applicable specifically for “suppliers of storage, warehousing, and secondary assembly and distribution services”.
This section reflects the differences in scope. The GDPMD scope is limited to importers, distributors and secondary assemblers (defined as companies engaged in packing the medical device, which is already in its labeled primary package, into its secondary package). GDPMD continues the spirit of ISO 13485 in allowing organizations to justify whether certain requirements are not applicable.
Normative References
Key differences:
- ISO 13485 makes reference to ISO 9000. GDPMD does not make such references.
This section further reflects the limited scope of GDPMD.
Terms and Definitions
Key differences:
Terms and Definitions
Key differences:
- GDPMD adds specific definitions on adverse effects, adverse events, certification bodies, distribution, export, field safety corrective action (FSCA), import, premises, packaging and secondary assembly.
- GDPMD uses the term “field safety notice” in place of ISO 13485’s “advisory notice.”
- While ISO 13485 includes definitions of active implantable medical device, active medical device, implantable medical device, labeling and sterile medical device, GDPMD includes a more comprehensive list of categories of devices in its Annex 2, which includes active implantable devices, anesthetic and respiratory devices, dental devices, diagnostic and therapeutic radiation devices, electro-mechanical medical devices, hospital hardware, in vitro diagnostic devices, non-active implantable devices, ophthalmic and optical devices, reusable instruments, single-use devices and technical aids for disabled persons.
The inclusion of additional definitions makes it easier for importers and distributors—many of whom may be inexperienced with postmarket surveillance and vigilance practices prior to HPA 2007—to comply. A list of medical device categories in Annex 2 corresponds to the available categories on a GDPMD certificate.
Quality Management System
General Requirements Key differences:
• GDPMD omits the detailed texts pertaining to identifying, analyzing and monitoring processes within the organization, and retains only that “…the organization shall ensure control over such processes.”
ISO 13485 uses the term “process” to refer to functions such as purchasing, receiving, quality control, manufacturing, shipping and more. Most organizations under the scope of GDPMD have relatively simple processes, therefore the text is simplified.
General Requirements Key differences:
• GDPMD omits the detailed texts pertaining to identifying, analyzing and monitoring processes within the organization, and retains only that “…the organization shall ensure control over such processes.”
ISO 13485 uses the term “process” to refer to functions such as purchasing, receiving, quality control, manufacturing, shipping and more. Most organizations under the scope of GDPMD have relatively simple processes, therefore the text is simplified.
Documentation Requirements Key differences:
- General: ISO 13485 requires a quality manual; GDPMD requires a site master file.
- General: ISO 13485 requires a separate file for each type or model of medical device; GDPMD makes no such requirement.
- Control of Documents: GDPMD requires documents to be controlled as with ISO 13485. However, texts related to documents of external origin, review and approval by the original approving function and defined period for retaining obsolete versions are removed.
The use of the term “site master file” instead of “quality manual” suggests that the documentation burden should be less than in ISO 13485. It is also expected that importers and distributors should have fewer types of controlled records compared to manufacturers.
Management Responsibility
GDPMD omits the entire sections on management commitment, customer focus, quality policy and planning, and retains only:
GDPMD omits the entire sections on management commitment, customer focus, quality policy and planning, and retains only:
- The sections on responsibility and authority and management remain basically unchanged, but are re-categorized under the “Resource management” section in GDPMD.
- The section on management review is basically unchanged, but is set apart in GDPMD as its own title section, “Management review.”
Importers and distributors are often small enterprises where the distinction between management and non-management is frequently irrelevant. Therefore, only the critical sections are retained in GDPMD.
Resource Management
Key differences:
Key differences:
- The section on the provision of resources is omitted in GDPMD.
- The section on human resources is renamed “personnel” in GDPMD. ISO 13485 states that “Personnel performing work affecting product quality shall be competent,” whereas GDPMD states, “Key personnel in charge of warehouse operations shall [be competent].”
- Sections on infrastructure and work environment are entirely rewritten under “premises and facilities,” which requires the organization to observe adequate premises and equipment, cleanliness and pest control.
Under GDPMD, warehouse personnel are considered key; therefore, personnel competency is specifically required. Similarly, the storage or warehouse area is considered key.
Specific statements on cleanliness and pest control borrowed from food and pharmaceutical GMP regulations allow storage and warehouse operators to respond more directly than the relatively general statements in ISO 13485.
Specific statements on cleanliness and pest control borrowed from food and pharmaceutical GMP regulations allow storage and warehouse operators to respond more directly than the relatively general statements in ISO 13485.