Inspection notebook

Inspecting notebooks, use-logs, facilities, lab operations and analyst s laboratory practices. 

At the beginning of an inspection, an individual inspection notebook is issued to each IT member. The inspector must record all information gathered during the inspection preparation phase and on-site activities in his/her inspection notebook. The notebooks never leave the custody of the IT. 

The HILL-SCAN 30XX boards can be used in different PCs. Desktop- and tower-PCs as well suited for laboratory uses. For in-field inspections rugged notebooks and portable PCs are advantageous. A typical portable system is shown in Fig. 2 (USPC 3010), used in MUSE (Mobile Ultrasonic Equipment). This portable PC not only contains the boards for ultrasonic testing but also a controller with power supply for stepper motors, so that a manipulator can be connected directly. The MUSE system is enlarged with a water circulation system which enables a local immersion technique" for in-field inspections. A typical result is shown in Fig. 3, which presents a D-scan of a CFRP- component in RTM-techniques. The defect area caused by an impact is clearly indicated. The manipulator is described in [3]. 

Planned maintenance programs are an essential weapon in a department s armory to ensure that the services it is called on in meeting its responsibilities are fully met. The traditional method of working from pieces of paper or individuals own notebooks as to when maintenance is to be carried out or when the insurance representative is due to visit to carry out an inspection are no longer satisfactory. This is especially the case when the skilled resources necessary to carry out the work are more difficult to obtain. 

Laboratory notebooks—It may be debatable to consider laboratory notebooks as text documents, but they should be mentioned here because of their importance in preclinical development. Laboratory notebooks are used to record experimental procedures, observations, raw data, and other important information. Although laboratory notebooks are rarely used for submission to regulatory agencies directly, they are available for inspection by the authorities in the Preapproval Inspection (PAI) and other GMP/GLP-related inspections. Currently, most of the major pharmaceutical companies still use paper-based laboratory notebooks. Electronic-based notebook systems are being developed and commercialized, which are discussed in Chapter 9. 

The first course of action would be for the analyst to inspect his/her technique, chemicals, notebook records, and perhaps the equipment used, to try to detect a determinate error. If a cause is found, then the measurement should be rejected and the reasons for such rejection documented. If a cause is not found, and if time is not a factor, it would be advisable to repeat the measurement, perhaps many times, to see if the anomaly appears again. If it does, the situation is not resolved unless a cause is established in the course of the repetition. If it does not appear again, its seriousness has diminished because there are more measurements from which the mean is calculated. 

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

Media-filled vials will be incubated in an upright position at two temperatures for a minimum of 14 days. The vials/ampoules will be inspected for growth at two separate times, once at a minimum of 7 days of incubation at 22.5 2.5°C and again at the end of the 14 days of incubation at 32.5 2.5°C. Record of these inspections will be documented in QC notebook. Any vials found positive for growth will be investigated as detailed in the acceptance criteria section of the SOP. 

The current good manufacturing practices (GMP) state that Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards [5]. This includes all electronic and hard copies of raw data, laboratory notebooks, and/or worksheets and reports. Additionally, the regulations require that records shall be readily available for authorized inspection [6]. Consequently, the organization must have a well-defined audit trail for the generation, storage, and retrieval of reports and raw data. It must also be shown that there is adequate document management and security of all raw data and reports in terms of both disaster recovery and prevention of falsification of results. 

The organization must have a well-documented audit trail to raw data that will facilitate the retrieval of any supporting data that may be required during a regulatory inspection. In case of any off-site inspection, it may be prudent to include a copy of all notebook pages and all raw data. 

Conventional method development records are typically not the subjects of regulatory review. Failures, which are commonplace in early method development, are rarely investigated or fully explained. Laboratories that plan to use development data in a validation must document their data in accordance with regulatory standards. Therefore, all entries must be recorded in laboratory notebooks that shall be readily available for authorized inspection [6]. 

Some authorities will insist on inspecting the documentation trail for process development, including laboratory notebooks. 

Because analytical results can be accumulated over long periods on easily accessible disks — a big improvement on laboratory notebooks — it is easier to evaluate the performance of a method or process over a period of time. It is easy to determine the frequency of defects in performance, both by inspection and by more formal methods. One of these which is being used more widely is the cusum procedure. A reference value, k, is selected typically it is the mean value of the expected result. Then sequentially the cumulative sum, Si is calculated... 

The records of the student s work are made in a bound notebook approximately 8 x 10 inches in size. This should always be brought to the laboratory by the student, and must be ready for inspection without notice. Loose-leaf books, individual sheets of paper on which notes are kept and later copied, are not acceptable to those working in the field of science. 

The laboratory notebook is a record of your job as an analytical chemist. It documents everything you do. It is the source for reports, publications, and regulatory submissions The success or failure of a company s product or service may depend oh how well you do that documentation. The notebook, becomes a legal document for patent issues, government regulation issues (validation, inspections, legal actions), and the like. Remember, if it isn t written down, it wasn t done. The notebook is where you record your orig- inal ideas thatmay form the basis of a patent arid so it is important to record what went into those ideas and when. 

The main equipment is obviously the human eye and brain, aided with a notebook, pro forma or hand-held computer and a camera. Binoculars may be necessary, but close inspection is better if access can be arranged. 

The main equipment is obviously the human eye and brain, aided with a notebook, pro forma or hand-held computer and a camera. Binoculars may be necessary, but close inspection is better if access can be arranged. A systematic visual survey will be planned in advance. Many companies that carry out condition surveys will have standardized systems for indicating the nature and extent of defects. These are used in conjunction with customized pro formas for each element or face of the structure. It is normal to record date, time and weather conditions when doing the survey, also noting visual observations such as water or salt run down and damp areas. Examples are given in Figures 4.1 and 4.2. 

Procedures for providing the representatives of the inspected State Party with copies of written information, inspector s notebooks, data and other material gathered by the inspection team ... 

Close-out Procedure—When your Notebook is full or if you transfer to another department or your department is reorganized, submit the Notebook without delay to the Research Section Manager, Senior Research Associate, or anyone above in line of supervision for inspection and approval. If the Notebook meets with approval for final registration and storage, the supervisor should stamp, sign, and date on the last page used or on the last page of a full Notebook. The stamp should read ... 

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