Laboratory Control System Operations in a GMP Environment. David M. BliesnerЧитать онлайн книгу.
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? | |
| 2.2 | Training and Qualification | |
| 2.2.1 | Have the educational, training, and work experience requirements for each laboratory position been clearly defined and do they reflect current standards in the industry? | |
| 2.2.2 | Is the requirement for training and qualification clearly described in an SOP or similar document for all laboratory managers, supervisors, analysts, support, temporary staff, and consultants? | Training is defined as an activity designed to provide the skills and/or knowledge that individuals need to perform assigned job-related duties and responsibilities.Qualification is defined as the process, including documentation and approval, whereby a person is trained and demonstrates proof-of-proficiency in specified tests, tasks, procedures, or techniques. |
| 2.2.3 | Has a training and qualification curriculum been developed for each position that clearly identifies training requirements for all required SOPs and Policies, Test Methods, Safety Procedures, and the GMPs as well as all other internal and external courses or programs? | |
| 2.2.4 | Is there a system in place (e.g. electronic, paper-based, or hybrid) to capture, track, and manage training and qualification of laboratory personnel? |
Electronic training systems should have a set of standard file + curriculum for each unique position on the organizational chart. For example, the position for a laboratory technician responsible for glassware washing should be loaded into the training system as if it |