Republic of the Philippines tenes FOOD AND DRUG ADMINISTRATION Mlaacnee 1] Alabang, Cty of Muntinlupa RFO/CO: IV-A/SLE CL - INSPECTION AGENDA _ - Name of Establishment — _ - - | Address | LTO Number Date/s of Inspection | Purpose of Inspection RA. 9711. FDA Act 2009, R.A. 10611, Food Safety Act 2013, Administrative Order Reference / Inspection | 1.5 153, «2904, A.0.2014-0029, A.O. 2014 - 0030, Certificate of Current Good Stendard Manufacturing Practice Taspection Day/Time Inspection Activity —] Travel Time Opening Mecting with company representative's 2. Introduction b. Attendance Record ©. Company Overview Observation on the following: a. Lay-out = Segregation from the different areas of operation | b. Personnel | = GMP Organization = Job Description = Training, Assessment and Performance Evalution = Physical Medical Exam forthe Personnel Sanitation & Hygiene = Housekeeping ~ Hygienic Practices including gowning = Surfaces & Finishes Pest Control Maintenance of the Premises / Areas of Operation Sanitation Process / Procedure 4. Production & Process Control ~ Process Flow ~ Mamufacturing Procedure = Batch Documentation © Quality Control = In-Provess Quality Control and Testing Procedure Inspection Agenda fiatRepublic ofthe Philippines Department of Health FOOD AND DRUG ADMINISTRATION Filinvest Corporate City i ‘Alabang, City of Muntinlupa g- Warehousing & Distribution ~ Source of RM / PM { ~ Receipt, Handling and Storage of Products | h, Documentation/Records Management & Control | i. Supplier/Vendor Evaluation, Approval and Monitoring | 4. Other SOPs : ~ Stock Handling and Control (including receiving/releasing oF products) | - Training ~ Risk Management Plan = GMP Agreement = Handling of Complaints = Handling of Product Recall Report Writing creed ceeeeees [Exit Meeting L Inspector/s —— Smee) MANILYN Y. CABRALES, RND saa Name & Signature) | (Print Name & Signature) Food-Drug Regulation Officer Food-Drug Regulation Officer 7 us Rea roved By: | MARIA LUISA L. DE SAGUN, RPB.MSe. ‘(Print Name & Signature) ‘Team Leader, Food-Drug Regulation Officer cee