Manual of Standard Operating Procedures and Policies
Regulatory - Compliance |
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Nomination and Approval of CBER Inspectors and Product Specialists Assigned to Conduct Inspections of Biological Products |
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SOPP 8505 |
Version #1 |
January 10, 2000 |
- Purpose
This Standard Operating Procedure (SOP) describes the policies and procedures for nominating and approving Center for Biologics Evaluation and Research (CBER) staff to conduct and/or participate in pre-license, pre-approval and post-marketing inspections of CBER regulated products. This SOP also applies to CBER staff assigned to participate in Team Biologics inspections.
- Background
The inspection of establishments that manufacture biological products is an integral part of the Center's strategy in the regulatory control of biological products. Biological products are inspected under the authorities of Section 351 of the Public Health Service Act (PHS Act) [42 U.S.C. 262] and Section 704 of the Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 374]. CBER has emphasized the need for biological product manufacturers to be in compliance with the applicable sections of the regulations promulgated under both the PHS and the FD&C Acts.
The authority and responsibility to approve CBER staff nominated to participate in the Center's inspection program has been delegated to the Office of Compliance and Biologics Quality (OCBQ). CBER staff approved by OCBQ to participate in inspections will be issued FDA credentials, which means that certain of the Commissioner's enforcement authority as specified in 21 CFR 5.35 are redelegated to the CBER inspector or product specialist. CBER staff assigned to conduct inspections represent the FDA and CBER. The Agency expects that the inspection authority will be used wisely and judiciously.
This document provides general information about the qualifications and requirements for Inspectors and Product Specialists. Training requirements are more fully described in the 1992 CBER Inspection Manual.
- Definitions
CBER application review staff who review for Good Manufacturing Practice (GMP) compliance (usually Division of Manufacturing and Product Quality staff) are given the Inspector title. CBER employees who participate in inspections as product experts, usually staff assigned to CBER product review offices, will be deemed Product Specialists. Members of the Office of Compliance and Biologics Quality, other than those described above, who participate in inspections will also have the Inspector title.
CBER employees who request credentials to participate in inspections, as either inspectors or product specialists, should be prepared to fulfill all of the obligations incumbent in performing inspections including, but not limited to, participating in pre-inspection meetings, adequate inspection preparation, contributing to the preparation of the Establishment Inspection Report, reviewing responses to FDA 483s, and supporting regulatory actions based on the inspectional findings.
In order to maintain flexibility in the inspection program, CBER has not established specific requirements for all inspectors or product specialists. The employee must demonstrate general knowledge of the areas described below, as appropriate, through either training or experience and must have demonstrated an ability to perform all of the required duties of an inspector or product specialist, as appropriate.
Inspector. Designated officers and employees of CBER authorized to conduct inspections, investigations, examinations, and sample collections, of biological products as authorized by law under Section 702(e)(5) and 704 of the FD&C Act, Section 351(c) of the PHS Act, and Title 21, Code of Federal Regulations, Part 600, Subpart C.
Inspectors must have current knowledge of laws and regulations including GMP regulations and Agency/Center policies applicable to the regulation of biological products. They should be knowledgeable about all aspects of GMP, including personnel qualifications, quality assurance and quality control methods, buildings and equipment, control and qualification of incoming materials and components, production and process controls, packaging and labeling controls, laboratory testing, and records and reports, as they pertain to product manufacturing. They should have attended training in inspection techniques. CBER inspectors should have a minimum of six months of agency experience, or the equivalent, to qualify for credentials. The training criteria for inspectors are more fully described in the CBER Inspection Manual.
Inspectors may cover multiple biological product lines and are not limited to a specialized area. Inspectors will generally lend coverage to the full scope of GMP, and have responsibility for other issues/assignments designated for coverage during the inspection and inspection follow-up activities.
CBER employees designated as inspectors will act as the inspection lead or team leader during pre-approval inspections. The Investigations Operations Manual, section 502.4, describes the role and responsibilities of the Team Leader for a team inspection. If an employee is granted credentials as an Inspector, the employee should be willing and able to take on the role and responsibilities of the inspection team leader if so requested.
Product Specialist. A CBER employee who is designated to participate as a product expert during an inspection of biological products.
As with Inspectors, Product Specialists are designated officers and employees of CBER authorized to conduct inspections, investigations, examinations, and sample collections, of biological products as authorized by law under Section 702(e)(5) and 704 of the FD&C Act, Section 351(c) of the PHS Act, and 21 CFR Part 600, Subpart C.
They must be knowledgeable of current issues in product manufacturing, including product process validation, product stability, product release testing methods, and other product specific issues. Product Specialists should have current knowledge of laws, regulations and Agency/Center policies applicable to the products in their area of expertise. They should have experience in conducting product reviews. Product Specialists should have, at a minimum, six months experience with the FDA, and have attended appropriate training in the conduct of FDA inspections and basic good manufacturing practice. Product Specialists may have more than one area of expertise and may be considered for inspections by more than one office.
To participate in Team Biologics inspections, product specialists should have attended the Team Biologics training course in their program area. This will be waived upon a showing that the employee has had comparable training and/or experience.
- Policy
It is the policy of CBER that qualified individuals will participate in CBER's inspection program as inspectors or product specialists. Individuals participating in inspections are expected to have current knowledge of the laws, regulations, and policies that pertain to their area(s) of inspectional responsibility. The approval of CBER inspectors and product specialists, including CBER staff who participate in Team Biologics inspections, is the responsibility of the Office of Compliance and Biologics Quality. FDA credentials will generally not be issued to CBER employees who are not actively engaged in conducting inspections.
- Responsibilities and Procedures
Division Directors or Branch Chiefs may nominate division staff as Inspectors or Product Specialists. The nominating division should submit a request for credentials to OCBQ for each staff member nominated. The request for credentials should include FDA Form 2115, Credential Record Form (see Attachment #1), and a memorandum summarizing the employee's qualifications and duties (see Attachment #2). The memorandum should be specific in addressing the professional expertise of the employee.
- For Product Specialists, the memorandum should describe the employee's knowledge of product manufacturing processes, process validation, stability requirements and product testing, and describe any applicable training the employee has had. FDA Form 2115 should describe in sufficient detail the duties of the employee, and state that the employee will be participating in inspections as a product specialist.
- For Inspectors, the memorandum should specify that the employee has knowledge of applicable laws and regulations, including an understanding of GMP; inspectional experience; completed training in inspections; and describe any applicable training the employee has had. FDA Form 2115 should describe in sufficient detail the duties of the employee, and state that the employee will be participating in inspections as an inspector.
- For Inspector or Product Specialist trainees, as described in the CBER Training Manual, the memorandum should specify any training the employee has had in areas pertinent to the inspections he or she will be performing. The memo should also indicate that the credentials are being requested so that the employee can receive on-the-job training in performing inspections.
The request for credentials should be forwarded by the employee's office to the Team Leader, Team Biologics Liaison Staff (TBLS), OCBQ, for review.
If the employee is approved for participation in the inspection program, the Director, OCBQ will sign the Credential Record Form. The signed form will be forwarded to the employee.
After approval by OCBQ for participation in the inspection program, the employee will be responsible for obtaining the signature of the authorizing official in Block 13 of the Credential Record Form and for obtaining the credentials. The authorizing official will direct the employee to the room where a photograph will be taken and the credentials issued.
The authorizing official is in the Division of Emergency and Inspectional Operations (DEIO) in Parklawn (HFC-132) 301-827-5653, room 1371.
Photographs are taken and credentials issued in Room 2078A, 5630 Fishers Lane (301-827-7214).
Credentials for Product Specialists and Inspectors will generally be valid for three years. Credentials for trainees will generally be valid for one year. Alternate expiration periods may be granted based on specific circumstances. Authorization for the re-issuance of expired credentials will depend upon the employee's participation in the Center's inspection program, and will be at the discretion of the TBLS Team Leader. The application for re-issuance of credentials should describe the employee's participation in inspections during the previous period in which he/she held credentials and any additional pertinent training the employee has had. Ordinarily, an employee with three-year credentials should have participated in three inspections during that period in order to have the credentials renewed. If the employee does not meet the criteria, the nominating official may request that this requirement be waived and provide justification for the request.
If an employee is disapproved for participation in the inspection program, the TBLS Team Leader will communicate the disapproval to the nominating official in writing, and will provide the reasons for the disapproval. Some examples of reasons for disapproval of credentials include, but are not limited to, the failure to demonstrate current knowledge of applicable laws and regulations or past failure to complete all inspection-related tasks in a timely fashion, such as preparation of establishment inspection reports. A nominee may be disapproved for credentials based on his/her performance during previous inspections.
If the employee wishes to appeal the decision to disapprove his/her nomination, the employee's Office Director may request that the Director, OCBQ, review the decision. The request should address the reasons given for the disapproval.
An employee's credentials may be revoked at any time prior to their expiration if the employee is not executing all of the duties of an Inspector or Product Specialist, as appropriate. In the event that it becomes necessary to revoke an employee's credentials, the Director, OCBQ, will notify the employee in writing, with a copy to the employee's office and division directors, and will provide the reasons for the revocation. The employee will be expected to turn in his/her credentials to the Team Leader, Team Biologics Liaison Staff within 10 days of the date of the notification. Failure to do so may result in disciplinary action. After such notification, the employee may not participate in any future inspections until the credentials are reinstated.
- Effective Date
January 10, 2000