by default, requiring a level of compliance with the GMPs by R&D laboratories.
2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)
Description of the Laboratory Managerial and Administrative Systems Sub Element
The Laboratory Managerial and Administrative Systems are those sub elements that provide the infrastructure for efficient and compliant operations of an analytical laboratory. It is sometimes difficult to directly relate items within this sub element to the Current Good Manufacturing Practices (CGMPs). However, deficiencies within this sub element, which cannot be directly attributed to the CGMPs, can lead to compliance failures. For example, 21 CFR Sections 210 and 211 do not specifically require that someone be assigned the duties of training manager. However, failing to have an individual responsible for training and consequently not having an effective training program can degrade the overall quality of data that is generated by laboratory personnel, and US Food and Drug Administration (US FDA) has cited companies for not having a training program for laboratory personnel [1].
The Laboratory Managerial and Administrative Systems sub element includes at least six individual topics. A laboratory that is in compliance with CGMPs should at least address each of these topics (as applicable). These topics include (i) Organizational Structure and Roles and Responsibilities, (ii) Training and Qualification, (iii) Laboratory Budgeting, Purchasing, and Requisition, (iv) Laboratory Administration and Operations, (v) Laboratory Chemicals, Solutions, Reagents and Supplies, and (vi) Laboratory Reference Standards and Solutions.
These six topics are listed within the text of the chapter along with some suggestions on what items should be addressed in each topic. The list of items under each topic is fairly comprehensive but may not be totally inclusive of all those components, which may constitute the sub element.
Contents of the Sub Element
The six topics mentioned earlier are presented in Table 2.1 in the form of questions related to each topic. For each topic, additional details, or “points to consider,” are offered along with notes and clarifications as appropriate. The questions, notes, and clarifications are all based on actual inspectional findings from Regulatory Inspectors or points that have been found to directly or indirectly impact compliant and efficient real-world Laboratory Control System operations.
It is envisioned that the below table may be used as a basis for:
Evaluating your own laboratory's managerial and administrative systems
Upgrading your own laboratory's managerial and administrative systems
Establishing your own laboratory's managerial and administrative systems if it is a new laboratory or if you are making substantial changes to an existing Laboratory Control System
Table 2.1 Components of the laboratory managerial and administrative systems sub element.
| # | Laboratory managerial and administrative systems sub element topic | Notes and clarifications |
| 2.1 | Organizational Structure and Roles and Responsibilities | |
| 2.1.1 | Are current organization charts available for review and are they accurate? | Organizational charts will be one of the first things an auditor will request when your laboratory is being inspected. Make sure the document is current and correct in order to make a good first impression. |
| 2.1.2 | Is there a policy/procedure that defines the responsibility and authority of the Quality Control (QC) unit? | |
| 2.1.3 | Have the responsibilities of each functional group and supervisor been clearly defined, including testing and operational requirements, Standard Operating Procedures (SOPs), and all other critical functions? | |
| 2.1.4 | Is an organizational structure in place which is properly staffed to assure that all required testing/monitoring and support activities are performed? | Section 211.25 Personnel qualifications of the Good Manufacturing Practices regulations states “(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.” This applies to the laboratory and failing to meet this requirement is often the root cause of many issues which occur in poorly operated QC laboratories. |
| 2.1.5 | Is the span of control and authority assigned to the QC laboratory adequate to allow proper execution of these activities? | |
| 2.1.6 | Is the ratio of supervisors to analyst appropriate? (A ratio of no more than 1 : 8 is recommended) | If a supervisor has to supervise more than eight employees directly, the effectiveness of their ability to do so decreases dramatically. |
| 2.1.7 | Are the roles and responsibilities for each position within the laboratory clearly defined? | |
| 2.1.8 | Are the roles and responsibilities for each position in the organizational chart defined in formal, controlled, accurate, and current job descriptions? | Up until recently, job descriptions were considered the purview of the human resources department and therefore did not fall under the umbrella of GMPs. This has now changed, and the general expectation of regulatory agencies is that job descriptions should be maintained and controlled like any other GMP document. |
| 2.1.9 | Are signature authority, responsibility, and accountabilities appropriate and clearly defined? | |
| 2.1.10 | Do systems exist to enhance communications, understanding, and working relationships between laboratory and Quality Assurance (QA) personnel? | A healthy, respectful relationship between QC and QA will do wonders for everyone's ability to manufacture, test, and, ship product. QC managers should encourage QA personnel to spend time in the laboratory and teach QA personnel as much about product testing and analytical techniques as they can. |
| 2.1.11 | Does a personnel performance evaluation system exist, which tracks laboratory personnel strengths and weaknesses and establishes a means to improve technical, administrative, and managerial skills? | Performance evaluation should not be a one-time-a-year event. A good leader will continually evaluate and assist their employees to become the best that they can be. |
| 2.1.12 | Does a master testing schedule or similar document(s) exist to ensure smooth and efficient work flow, and minimize laboratory personnel over-commitment? | |
| 2.1.13 | Are current copies of CV's and resumes for all personnel, including consultants, available for review? |
