UTILITY REQUIREMENTS FOR STERILE PRODUCT MANUFACTURING Any utility in direct product contact is subject to formal qualification through the confirmation of the quality of the delivered material at each use point. Water-for-injection (WFI) systems are considered the most critical of all, and the qualification period for WFI is the longest and may be as long as … Read more
FBD Machine Fluid bed dryer – FBD is a processing unit for the Drying of granulated materials for solid dosage forms in batch operations. The Fluid Bed Processor is designed for Drying, Granulating, and Coating. The processor runs in a batch operation. The heated inlet air homogeneously flows through the specially designed perforated sheet into … Read more
Non-viable particle count in classified To establish the written procedure for monitoring of non-viable particle count in the classified Area S mall Volume Parenteral section. DEFINITIONS Clean Area: An area in which defined environmental control of particulate & microbial contamination, is constructed & used in such a way as to reduce the introduction, generation,& retention … Read more
LINE CLEARANCE CHECKLIST FOR DISPENSING AREA Check the Cleanliness of Dispensing area and RLAF & its filter. RLAF unit is operating for at least 15 minutes prior to dispensing. Are all the remnants of the previous product removed? Check the status board of dispensing area for the following details: Product Name, Batch No, Mfg. Date, … Read more
PRECAUTIONS & GENERAL INSTRUCTIONS IN DISPENSING AREA Check and ensure the environmental condition of the area e. Temperature and Relative Humidity are within the acceptable limits i.e. (Temperature NMT 270C, RH NMT 50 %) Use personal protective aids while handling the material. Ensure that the line clearance shall be performed before starting each stage of … Read more
Codeine Phosphate and Chlorpheniramine Maleate Syrup Dosage Form – Oral Liquid Dosage Form Average fill – 100 ML Label Claim – Each 5 ml contains: Codeine Phosphate IP 10 mg Chlorpheniramine Maleate IP 4 mg In a pleasantly flavored syrupy base Colour: – Sunset Yellow FCF. Product Generic Name: Codeine Phosphate and Chlorpheniramine Maleate Syrup. … Read more
LINE CLEARANCE FOR THE SUGAR MANUFACTURING AREA BMR is available & complete till Stage. Check the “Status Board” of the area for the following details: Product Name, Batch No., Mfg. Date, Exp. Date, Batch Size, and match with BMR. Verification of cleaning of light fixtures, return air risers, & supply air risers during line clearance … Read more
PRECAUTIONS & GENERAL INSTRUCTIONS IN MFG AREA Ensure area and equipment cleanliness before starting the manufacturing operations. Check and ensure that all manufacturing equipment and other required accessories are clean and ready for use. Wear Gloves and Nose masks during all manufacturing processes. Counter-check the weights of all ingredients before using them in the batch. … Read more
Checklist for Precautions during working on Analytical Weight Balance (Before weighing) Checklist for Do’s Check calibration of balance before weighing Always ensure that the spirit level of the analytical balance is proper. Check silica gel for activation (dark blue) if not then dry it in the Oven till the color changes to dark blue. Use a … Read more
Checklist for sample preparation Checklist for Do’s Use a heating mantel or burner with glass beads to avoid bumping. Specific gravity – check the temperature during the analysis Weight/ml – avoid air bubbles in the tube. Polarimeter – Avoid air bubbles in the cell. For melting point, powder the substance to fine particles & fill in … Read more