gooddocumentationpractices-sanmateocountycommunity（13页）.docVIP

Good documentation Practices. Introduction: In a facility that uses Good Manufacturing Practices (GMP), numerous types of documentation exist and serve a variety of functions. Examples of the functions of documentation include: providing a record of what was done, instructing an individual on how to perform tasks, defining specifications, ensuring traceability, and providing evidence that a product was made according to regulatory or in house requirements. The following lesson will help provide you with some of the minimum standards, reasoning and rules that you will be required to provide when completing current Good Manufacturing Practices (cGMP) documentation. Contents Objective Background Documentation Rules Glossary References Laboratory Objectives: On this document write out the location of the information given by each of these questions by circling and printing the number in that area. Describe the functions of documentation. List the different types of laboratory documentation that you learned in class. What is the purpose of keeping a laboratory notebook? What id the difference between a SOP and a protocol. What type of documentation do you usually record in a logbook? How are labels used in a manufacturing facility? What should be the contents of a laboratory label? Given a new use design a label for use. How are the following used in a biotech laboratory? Master Batch Record, SOP, label, forms and logs, training records, numbering system and product release certificate. In your own words describe what good documentation practices are. What are the rules for writing in cGMP documents? What is the proper method for recording time in a cGMP document? What is the proper way to make corrections? What is the correct way of handling raw data? What is signature verification? How does one use a SOP and a master batch record? How does one make entries in a laboratory notebook? What are the usual components of an SOP.? How does one write out an