An excerpt from the new e-book Core Processes in the Pharmaceutical Laboratory
Equally important is a timely and proper outward transfer of the substances from the workflow!
The process from procurement of the substances to their disposal is shown in Figure 1.
Figure 1 Workflow for standard substances and reagents
Reagents and standard substances should be delivered to a specially designated area. Operational areas should not have direct access to this area. Provisions should be in place for storage of quarantined goods under the specified storage conditions (e.g. chilled and frozen storage, uninterrupted cold chain). This also applies to the rooms themselves (controlled room temperature).
The first step is to check the accompanying documentation of the delivered substances for completeness (compare the delivery note with the goods delivered) and for the correctness and integrity of the delivery (visual inspection). If goods are delivered under controlled conditions, the respective data logger must be checked for alarm messages and evaluated. If the required evaluation software is not available, the logger can be returned to the sender for evaluation. Particular attention should be given to photosensitive substances (light protection) and hygroscopic substances (desiccants), because the storage requirements must also be met.
The substance data is entered in a paper-based or electronic management system (LIMS) and checked (4-eyes principle). After approval by a manager and proper labelling, the substances can be moved out of quarantine to their storage location or user.
When the substances are handled in the operational area, the analyst is responsible for their correct and proper use. Before use, the material safety data sheets must be read. The reagents and standard substances also undergo a visual inspection before use during which the intended use and expiry date are checked. If containers are opened, this information should be entered in the management system. The labelling of reagent or standard solutions prepared in the laboratory is carried out in such a way that traceability of the starting materials is guaranteed.
The process used for returning empty containers or expired reagents and standards (into quarantine) should be clearly defined in the workflow and monitored on a daily basis by senior managers (e.g. QC or QA). All substance-related data should be checked in the management system, i.e. correct storage conditions and expiry dates.
Substances that undergo retesting remain in quarantine until a valid certificate is provided before they are returned to the workflow using a controlled process.
Are you responsible for quality control in your company?
Would you like to make sure that your quality control laboratory implements the complex GMP requirements?
How do you avoid possible mistakes and ensure the safe production of pharmaceuticals?
This e-book provides you with the basic information you need - many illustrations, examples, tables and checklists enable you to quickly familiarise yourself with the topic. You will find regulatory requirements, methodological principles and practical implementation proposals on the following topics: