Handbook of Pharmaceutical Manufacturing Formulations - by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

The 5th quantity within the sequence, this ebook covers over the counter items, which come with formulations of goods categorised via the U.S. FDA lower than the OTC type. each one access starts off with a completely confirmed scaleable production formulation and a precis of producing technique. The e-book presents a close dialogue at the problems encountered in formulating and production OTC items. The part on Read more...

content material: ebook hide; Half-Title; name; Copyright; commitment; Preface to the sequence; Preface to the quantity; in regards to the writer; Acknowledgments; desk of Contents; half I Regulatory counsel; half II over the counter Product Formulations; half III Appendix.
summary: The 5th quantity within the sequence, this booklet covers over the counter items, which come with formulations of goods categorised by means of the U.S. FDA less than the OTC type. every one access starts with a completely established scaleable production formulation and a precis of producing strategy. The publication offers an in depth dialogue at the problems encountered in formulating and production OTC items. The part on regulatory and production advice offers with the themes of cGMP practices for the OTC drug items, formulations of sturdy oral dosage types, oral ideas and suspensions, validation

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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations - Over-the-Counter Products (Volume 5 of 6)

Example text

Establish what temperature, humidity, and dust-collecting controls are used by the firm in its manufacturing operations. Lack of temperature and humidity controls can affect the quality of the tablet. Record that powders or granulations are processed according to the standard operating procedures (SOPs). The mixing process must be validated. The drying ovens should have their own air-handling systems to prevent cross-contamination. Firms should maintain charts of drying times and temperatures and should include loss-ondrying test results.

Any colors should be checked against the Color Additives Status List in the Investigation Operations Manual of the FDA (IOM) to ascertain if they are approved for their intended use and that the required statements are declared on the drug labels. When components are received at more than one location, they must be handled in accordance with the drug © 2004 by CRC Press LLC cGMPRs, including components used in research and development laboratories. Components must be identified so the status (quarantine, approved, or rejected) is known.

To prevent cross-contamination, the mixing, granulation, drying, and/or tableting operations should be segregated in enclosed areas with their own air-handling systems. Document what precautions are being taken to prevent cross-contamination. When cross-contamination is suspect, investigate the problem and collect in-line samples and official samples of the suspect product. Establish what temperature, humidity, and dust-collecting controls are used by the firm in its manufacturing operations. Lack of temperature and humidity controls can affect the quality of the tablet.

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