General Provisions and Requirements

General Provisions and Requirements Applying to Specifications, Tests, and Assays of the Food Chemicals Codex... 

Subpart A, General Provisions and Definitions. It sets forth the minimum current good compounding practices for the preparation of drug products by state-licensed pharmacies for dispensing and/or administration to humans or animals and includes definitions and requirements, as follows ... 

Perform a blank determination (see General Provisions), and make any necessary correction. Two milliliters of 0.1 N perchloric acid is equivalent to 26.23 mg of C H CatV Acidity or Alkalinity Add some drops of methanol, 30 mL of water, and several drops of phenolphthalein TS to 1 g of sample. If the mixture is colorless, titrate with 0.1 N sodium hydroxide to a pink color that persists for 15 s. Not more than 1.0 mL is required. If the mixture is pink, titrate with 0.1 A hydrochloric acid. Not more than 1.35 mL is required to discharge the pink color. 

Assay With the aid of about 25 mL of water, transfer about 125 mg of sample, accurately weighed, into a 300-mL Erlen-meyer flask. Add 50.0 mL of 0.5 N potassium dichromate, mix, then carefully add 100 mL of sulfuric acid, and heat to boiling. Remove the mixture from the heat, allow it to stand at room temperature for 15 min, cool it in a water bath, and transfer it into a 250-mL volumetric flask. Dilute almost to volume with water, cool to 25°, then dilute to volume with water, and mix. Titrate a 50.0-mL aliquot with 0.1 iV ferrous ammonium sulfate, using 2 or 3 drops of orthophenanthroline TS as the indicator, and record the volume required, in milliliters, as S. Perform a blank determination (see General Provisions), and record the volume of 0.1 N ferrous ammonium sulfate required, in milliliters, as B. Calculate the percent cellulose in the sample by the formula... 

Readily Oxidizable Substances (as formic acid) Dissolve 15 g of sodium hydroxide in 50 mL of water, cool, add 6 mL of bromine, stirring to effect complete solution, and dilute to 2000 mL with water. Transfer 25.0 mL of this solution into a 250-mL glass-stoppered Erlenmeyer flask containing 100 mL of water, and add 10 mL of a 1 5 aqueous solution of sodium acetate and 10.0 mL of sample. Allow to stand for 15 min, add 5 mL of a 1 4 aqueous solution of potassium iodide and 10 mL of hydrochloric acid, and titrate with 0.1 N sodium thiosulfate just to the disappearance of the brown color. Perform a blank determination (see General Provisions), and make any necessary correction. The difference between the volume of 0.1 IV sodium thiosulfate required for the blank and that required for the sample is not more than 2.2 mL. 

Assay Dissolve about 100 mg of sample, accurately weighed, in 20 mL of water add 40.0 mL of 0.1 N ceric sulfate prepared as directed for Volumetric Solutions under Solutions and Indicators (or use a commercially available solution) mix well and add 2 mL of silver sulfate solution (5 g of Ag2S04 dissolved in 95 mL of concentrated sulfuric acid). Cover, heat nearly to boiling, and continue heating for 30 min. Cool to room temperature, and titrate with 0.1 A ferrous ammonium sulfate to a pale yellow color. Add 2 drops of orthophenanthroline TS, and continue the titration to a salmon-colored endpoint, recording the volume required, in milliliters, as S. Perform a residual blank titration (see General Provisions), and record the volume required as B. Each milliliter of the volume B - S is equivalent to 2.650 mg of NaH2P02H20. 

Saponification Value Transfer 2 g of sample, accurately weighed, into a 250-mL Erlenmeyer flask. Dissolve in 25 mL of a 2 1 toluene isopropyl alcohol mixture. Using a volumetric pipet, add exactly 50.0 mL of 0.1 N methanolic potassium hydroxide. Connect a condenser to the flask, and reflux gently until the sample is completely saponified (usually 30 min). Cool to room temperature, wash the condenser with a few milliliters of water, add 2 to 3 drops of phenolphthalein TS, titrate the excess potassium hydroxide with 0.1 N hydrochloric acid, and record the total volume of acid required. Perform a blank determination (see General Provisions), and make any necessary correction. Calculate the saponification value by the formula... 

Mexican law does not restrict payment of a doctor for both expenses and time invested in scientific meetings. However, the code of ethics of the National Chamber for the Pharmaceutical Industry has general provisions that require companies to act responsibly in donations and sponsorships. 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

The essential requirements in the MDD fall under two headings general requirements and requirements regarding design and construction. The general requirements include the following provisions ... 

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