Pharmacy

Handbook of Pharmaceutical Manufacturing Formulations, by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

Providing methodologies which could function a reference aspect for brand new formulations, the second one quantity covers uncompressed solids, which come with formulations of powders, pills, powders prepared for reconstitution, and different related products.

Highlights from Uncompressed sturdy items, Volume Two include:

  • the basic problems with solid production practices
  • formulations for greater than four hundred pharmaceutical items, together with at present authorized items and cutting edge items corresponding to small proteins, immediately liquifiable powders, and nanoparticles
  • access to US FDA guidance, in addition to all significant guidance round the world
  • identification and inclusion of the main usually authorized drugs and powders within the US

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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 2: Uncompressed Solid Products

Sample text

125 Labeling issuance a. Strict control shall be exercised over labeling issued for use in drug product labeling operations. b. Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records. c. Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data.

Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions. d. 160(b)(4). e. 166. 196 Distribution records: Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical 17 gas products, distribution records are not required to contain lot or control numbers.

The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified. b. Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to ensure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

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