The amount of time needed to comply with 21 CFR Part 820 (GMP) can vary widely from company to company. Over the years our experience has shown that most medical device and IVD manufacturers implementing FDA GMP quality systems are able to comply with GMP in three to seven months. The reason the process takes so long is that formal procedures specific to your company must be written AND utilized over a period of several months. You will need these official records if your company is inspected by the FDA. Those inspections can happen at any time.
Factors Affecting GMP Implementation Duration
Several factors can further impact how long it takes to get your FDA GMP quality system up and running:
Commitment of senior management – If your senior management sees FDA GMP implementation as just another regulatory annoyance, implementation delays often result. When senior management offers total support for QMS implementation as a way to better address customer requirements, mitigate risk and maintain effective processes, implementation is achieved faster.
Dedication of internal resources – Besides top-level support, proper allocation of in-house resources is crucial for successful completion of an FDA GMP quality system. This is especially important if your firm needs to commercialize a product as soon as possible to start generating sales. Hiring Emergo Group will speed your implementation process considerably, but you will still need to appoint an in-house person responsible for implementing the procedures we help write on your behalf. Your chosen internal staff member should have management authority within your company, and working with Emergo Group on the QMS implementation project will consume 25 to50% of their time over a six-month period. It is critically important to appoint an internal staff member to oversee your project.
Company size and complexity of manufacturing – Size and complexity of a manufacturer are also huge factors in how long it takes to implement a QMS. A firm with less than 50 employees and one location can typically launch a quality system in less time than a larger firm with multiple locations or complex manufacturing practices. Larger, more complex companies require more procedures and more resources—but in some instances can dedicate more resources to FDA GMP QMS implementation and maintenance efforts than smaller manufacturers. In addition, firms that have already set up ISO 13485 or ISO 9001 quality systems will require considerably less time to implement an FDA GMP QMS.
Stages of the FDA GMP Quality System Implementation Process:
Shown below is a typical timeline for implementing a GMP quality system for a mid-sized medical device manufacturer.
Weeks 1-2: Analysis, Planning and Project Kickoff
- Define scope of implementation
- Appoint management representative
- Conduct gap analysis audit to determine focus area
- Define objectives and create task list
- Conduct training for employees on FDA 21 CFR Part 820
Weeks 3-16: Documentation Development and Implementation
- Develop quality policy, objectives and manual
- Review current policies and procedures
- Write new Standard Operating Procedures (SOP) and review Work Instructions
- Start using new procedures to generate auditable records
Weeks 17-18: Internal Auditing
- Conduct internal audits
- Conduct management review meeting
- Train internal auditors
Weeks 19-21: Audit and System Refinement
- Conduct pre-registration audit and final readiness review
- Make post-audit modifications as needed
- Address remaining issues