Standard Operating Procedure for code of conduct during regulatory inspection in pharmaceutical facilities
1. Purpose
To provide a standard operating procedure of code of conduct by employee of pharmaceutical organization during onsite regulatory inspection.
2. Scope
The scope of this SOP is applicable to follow the code of conduct to be followed by employees during Regulatory inspection such as domestic regulatory bodies, US FDA, MHRA, EU, Health Canada, Ukraine or any other Country regulatory inspection at [company name].
3. Responsibility
All employees: To follow the code of conduct during regulatory inspection.
Head of Departments: To ensure compliance of SOP and to provide guidance to all department personnel.
4. Definitions
Not applicable
5. Procedure
● Regulators who does the inspection of pharmaceutical organizations works to ensure public health and safety and to ensure that the society gets quality and efficacious medication.
● To ensure the safety and security of Regulatory inspectors, auditors and regulators who do carry out pre-approval, or periodic GMP inspection of pharmaceuticals, bio-pharmaceuticals or medical device facilities’ inspection is prime importance and responsibility of manufacturing facility management.
● Therefore, it is mandatory to follow the below directions by all the employees present at [company name].
● Leaders such as factory managers, quality head, all department heads/ designee must ensure that their team members will follow and adhere to the code of conduct instruction provided as follows.
● Employees must not reveal the names, accommodation details or other relevant details of auditors/ inspectors on a public forum or on social media flat forums.
● Information related to transport mode, travel route, timings of the auditor/ inspector must remain confidential. This information must remain within the company and to the limited people.
● Do not try to establish contact with any regulators, auditors or inspectors who are performing audits other facilities unless they does contact to you.
● Do not share information related to the running inspection with other companies/ organizations/ on social media platforms. The information must remain with personnel within the company who are associated with the inspection process or allowed by leaders of an organization.
● Do not reveal any information regarding the audit/ inspection in public until inspection is completed and relevant responses to the audit finding is completed.
● Avoid reveling company information to others who are not employee of an organization and who are not associated with inspection process.
● It is also employees moral responsibilities to ensure confidentiality of company information.
6. Frequency
To follow code of conduct during all running regulatory audits or inspection carried out at [facility].
7. Formats
Not Applicable
