Pharmacokinetic Principles A drug should be able to reach its intended site of action after administration by some convenient route. In some cases, a chemical that is readily absorbed and distributed is administered and then converted to an active drug by biologic processes—inside the body. Such a chemical is called a prodrug. In only a…
Pharmacodynamic Principles Most drugs must bind to a receptor to bring about an effect. However, at the molecular level, drug binding is only the first in what is often a complex sequence of steps. Types of Drug-Receptor Interactions Agonist drugs bind to and activate the receptor in some fashion, which directly or indirectly brings about…
Water for Injection Water for Injection is sterile, nonpyrogenic, distilled water in a single-dose container for intravenous administration after the addition of a suitable solute. It may also be used as a dispensing container for diluent use. The pH is 5.5 (5.0 to 7.0) Water for Injection is used as an excipient in the production…
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…
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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…
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…
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,…
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…
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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….
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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…
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