Manufacturing process instructions

Creation of written specifications and manufacturing process instructions (MPIs) for... 

SPECIFICATIONS (MATERIALS, PROCESSING. INSPECTION.TESTING) MANUFACTURING PROCESS INSTRUCTIONS... 

Knob-twiddler (manufacturing) A person who has a propensity for changing things, often disregarding the Manufacturing Process Instructions (MPIs). 

Manufacturing process instructions (MPIs) Detailed instructions for the performance of each operation and the use of specific equipment, based on the specifications, that applies to each stage of the process flow. MPIs are developed based on the specifications. See also Process flow diagram Specifications. 

Shall A term used in specifications or manufacturing process instructions (MPIs) that indicates a mandatory procedure. Example The gloves shall be discarded after each use. See also May Should. 

Training The instruction of an operator in the proper procedures and techniques, as defined by the Manufacturing process instructions (MPIs). 

Batches and Recipes Each batch of product is manufactured in accordance with a produc t recipe, which contains all information (formula and processing instructions) required to make a batch of the produc t (see Fig. 8-56). For each batch of product, there will be one and only one product recipe. However, a given product recipe is nor-... 

A completed Form R must be submitted for each toxic chemical manufactured, processed, or otherwise used at each covered facility as prescribed in the reporting rule in 40 CFR Part 372 (published February 16,1988 in the Federal Register). These instructions supplement and elaborate on the requirements In the reporting rule. Together with the reporting rule, they constitute the reporting requirements. All references in these instructions are to sections in the reporting rule unless otherwise indicated. 

Answer this question only after you have completed the rest of the report. The specific identity of the toxic chemical being reported in Part III, Sections 1.2 and 1.3, may be designated as trade secret. If you are making a trade secret claim, mark yes" and proceed to Section 1.2. Only check "Yes" if it is your manufacturing, processing, or use of the chemical that is a trade secret. (See page 1 of these instructions for specific information on trade secrecy claims.) ff you checked "no," proceed to Section 1.3 do not answer Section 1.2. 

In the construction of new plants and equipment, the employer is responsible that the equipment is suitable for the process application. Checks and inspections are performed to assure that equipment is installed properly, and consistent with design specifications and the manufacturer s instructions. Maintenance materials, instructions, spare parts and equipment will he available... 

Manufacturing formulae should clearly indicate the product name, potency or strength, and exact batch size. It lists each of the starting raw materials required, and the quantity in which each is required. The processing instructions should contain step-by-step manufacturing instructions. The detail given should be sufficient to allow a technically competent person, unfamiliar with the process, to successfully undertake the manufacturing procedure. 

FDA inspectors are instructed to look for any differences between the process filed in the application and the process used to manufacturer the bio/clinical batch. Furthermore, one of the main requirements of a manufacturing process is that the process will yield a product that is equivalent to the substance on which the biostudy or pivotal clinical study was conducted. Validation of the process development and scale-up should include sufficient documentation so that a link between the bio/clinical batches and the commercial process can be established. If the process is different after scale-up, the company has to demonstrate that the product produced by a modified process will be equivalent, using data such as granulation studies, finished product test results, and dissolution profiles. 

In order to develop a reproducible manufacturing process, attention must be given to particular instructions and screening procedures. For instance, excipients should be free of lumps and proper screening will aid raw material dispersion. Additionally, one should specify the size and design of containers and all equipment to be used. 

Standard operating procedures will be required as written instruction to operating personnel on how to operate the manufacturing process. These will cover operation in conjunction with the computer system and also any tasks that are independent of the computer system. Where there is a requirement for quality-critical data to be manually entered on the computer system, there should be an additional check on the accuracy of the entry. If the computer system is not designed to carry out and record this check, then the relevant SOP must include this check by a second operative. 

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