Production management requirements for eye drops in dust-free workshops?-Frequently asked questions
Production management requirements for eye drops in dust-free workshops?
The preparation process of eye drops in dust-free workshop, including weighing, batching and inspection process, check the name, specification, batch number, manufacturer and quantity of raw and auxiliary materials according to the production prescription before weighing, and should have an inspection report; raw and auxiliary materials The calculation and weighing of the feeding amount must be reviewed, the operator and...
Text label: eye drops dust-free pharmaceutical cleanroom, production management requirements, design and installation of purification pharmaceutical cleanroom
Production management requirements for eye drops in dust-free workshops?
The preparation process of eye drops in dust-free workshop, including weighing, batching and inspection process, check the name, specification, batch number, manufacturer and quantity of raw and auxiliary materials according to the production prescription before weighing, and should have an inspection report; raw and auxiliary materials The calculation and weighing of the feeding amount must be reviewed. The operator and reviewer should sign the original record. The remaining raw materials should be sealed and stored, and the product name, batch number, date, remaining amount and the user's signature should be marked outside the container; It should be calibrated before each use and regularly inspected by professionals in the measurement department. Inspection verification and inspection records are required to be archived; each ingredient container must be marked with the full name, specification and production batch number of the preparation solution; filters and contacting equipment must be used before and after use. Wash with water for injection; after content determination and PH test are qualified, it can be potted. If the content is adjusted, it must be re-tested.
Bottle washing process: The eye drop bottle is removed from the outer packaging in the preparation room and sent to the washing room; the eye drop bottle is washed with an appropriate washing method; the quality of the bottle washing is regularly checked and recorded. The equipment and treatment methods used for filtration and sterilization should meet the process requirements. The integrity test of the microporous membrane should be done before and after use to ensure its sterilization effect. The sterilizer should have automatic recording and time monitoring devices for temperature and pressure. ; Sterilize according to the batch number, and do not mix batches. The intermediate products before and after sterilization should have reliable measures to prevent mixed batches; the sterilization equipment must be verified before use, and after the process is changed or overhauled, it must be re-verified to ensure the The temperature uniformity and sterilization effect should be verified before the sterilizer is used, and records should be recorded; when using disinfectants for disinfection, there should be two or more rotations to prevent the production of drug-resistant strains. The containers, pipes and accessories filled in the dust-free workshop should be washed with water for injection before use, and the hoses should be selected from those that do not remove particles; the containers should be sealed, and the air must be filtered; the filling volume and Insoluble foreign matter is clarity, and make a record. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for dust-free workshops and purification workshops.
The name, specification, batch number and quantity of the finished product should be checked before packaging in the dust-free workshop, which should be consistent with the packaging materials and labels used; the product name, specification and batch number should be checked at any time during the process of labeling, packaging and packing. ; At the end of the packaging, the number of labels used, the number of practical use and the remaining number should be accurately counted, and the remaining labels and scrap labels should be handled according to regulations; after the packaging is completed, after passing the inspection, it will be put into the finished product warehouse with the finished product inspection report. Visible foreign matter inspection includes light inspection method and light scattering method. Generally, light inspection method is commonly used. For colored transparent containers and packaging or liquids with darker color, the light scattering method should be used, and the introduction of visible foreign matter should be avoided during detection. The standards and methods are tested one by one; the inspected semi-finished products should be marked with the inspector’s name and code, and the post should be inspected by a special person. If it does not meet the requirements, it should be reworked and re-inspected; the qualified and unqualified products should be classified and stored. , and keep records.
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