模版3产品工艺验证审计（Template 3 product process audit）.docVIP

模版3产品工艺验证审计（Template 3 product process audit） Template 3: product process audit Write instructions: 1. this template applies to process validation audits in pharmaceutical manufacturing enterprises. 2. suggestions for each form of enterprises every year at least 1-2 selected high risk varieties according to the template process validation audit. 3. a record form is only applicable to the audit of one product. 4. all types of audits are issued with an audit report. 5., the audit conclusion should be able to reflect the overall situation of enterprise process verification, and give clear conclusions. Essential information Audit object: Dosage form name specification Audit date: Audit team members: Name: Department Checklist of main contents of audit: 1, product situation 2, quality standards 3 、 verification plan and report 4 、 verification record 5, inspection results 6, re verification Other: _____________ Audit conclusion: Upon review of the above, the product process is validated.......... audit report I. brief introduction to the basic situation Two, the main issues and risk assessment Major issues: Through the comprehensive evaluation of the above issues, the quality department of the enterprise has the following risks in the quality management system as well as the quality and safety of the products: Three, rectification proposals and follow up the inspection results Including the existing problems of the rectification proposals, rectification time limit, recommendations, follow-up inspection and so on. Four signature of audit team members Audit record 1. product situation YES NO 1.1 producing dosage forms 1.1.1 drug name and dosage form: Is 1.1.2 a sterile product? Is 1.1.3 a special product? 1.2 verify the critical control points of the process: 2. quality standards YES NO 2.1 is the production process in accordance with the statutory approval document? 2.1.1 countries approve products of the manufacturing process and review whether they are consistent with t