Tiêu đề Process Validation Protocol Template for Oral liquid-Suspension.pdf ✅

Protocol No.: Process Validation Protocol for Oral liquid/Suspension Quality Assurance Department Page 1 of 24 Title : Validation Protocol for B. No. : Prepared By Checked By Approved By Formulation: Oral Liquid Product’s Name: Reason for Performing the Validity Study: Reason ( tick which ever is applicable) Remarks Department New product Modification in the manufacturing process. Change in Facility and / or location of manufacturing. Batch fails to meet product & process specifications. Number of batches studied: First Three Batches Batch numbers: 1. 2. 3. Validation activity Approved by: _____________________________Date:_______________________ Validation Team: Department Validation Team Production Quality Control Quality Assurance Approvals: Department Sign & Date Production Engineering Quality Control Quality Assurance www.pharmaceuticalsky.com
Protocol No.: Process Validation Protocol for Oral liquid/Suspension Quality Assurance Department Page 2 of 24 Title : Validation Protocol for B. No. : Prepared By Checked By Approved By 1.0 General: 1.1 Introduction: The process validation will be performed as prospective validation. The complete documentation for the validation comprises several independent documents; references to relevant documents will be given as part of this protocol, (see below). The results of the validation activities will be summarized in the validation report. 1.2 List of Documents for Validation: Validation protocol, Details of sampling for the validation batches, test parameters (Product performance characteristics) with reference to test methods & Acceptance criteria. (acceptable Limit) Methods for recording / evaluating results including statistical analysis. Reference to relevant documents. 1.2.2 Batch manufacturing records. Detailed manufacturing instructions for the production of the validation batches. 2.0 Personnel Responsibilities: Sr No Activity Responsibility Remarks 1 Preparation of validation protocol QA Department 2 Review of validation report. Q.A In charge 3 Production of validation Batches Production In charge 4 Testing of validation samples & Preparation of validation report Q.C In charge 5 Approval of Validation protocol Manager (Q.A) www.pharmaceuticalsky.com
Protocol No.: Process Validation Protocol for Oral liquid/Suspension Quality Assurance Department Page 3 of 24 Title : Validation Protocol for B. No. : Prepared By Checked By Approved By 3.0 Process Description / Flow Sheet The information given below provides a general description of the process. Detailed information for the manufacturing will be supplied separately in the batch manufacturing record. 1 DISPENSING OF MATERIAL 2 SUGAR SYRUP PREPARATION 3 BULK MANUFACTURING 4 PH ADJUSTMENT 5 VOLUME MAKE UP 6 FILTRATION 7 WASHING, FILLING AND SEALING 3.1 Formulation: Batch Size: Sr No Ingredients/Excipients Unit per ml Quantity in Kgs Overages Quantity with Overages Dispensed Quantity Function 1 2 3 4 5 www.pharmaceuticalsky.com