Significance of Setting-up In-Process Controls and Specifications

May 6, 2013 By

In-process controls and specifications are a means of ensuring that a dietary supplement is manufactured, packaged, and labelled in a manner that will ensure that the quality of the dietary supplement is maintained and that the product is produced as per the master manufacturing record.

Production, quality control, raw material receiving, laboratory operations, manufacturing operations, and packaging and labelling are all factors that must be addressed when setting up in-process specifications and controls. Meeting in-process specifications should guarantee that the finished product will meet all of its specifications without having to be re-worked. The goal of the master manufacturing record and in-process controls are to avoid adulteration and contamination to the finished product and to ensure that the quality of the product is not compromised anywhere throughout the manufacturing process. In-process controls also give an opportunity for the manufacturer to look at all critical control steps in the manufacturing process and decide where the product quality could be compromised and put in place specifications to test against at those critical control points to identify possible deviations.

21 CFR part 111 subpart E requires that quality control personnel review and approve a justification of why meeting in-process specifications in combination with component specifications will ensure all product specifications are met for identity, purity, strength, and composition and the limits for contamination of microbiological, heavy metals, and other applicable contaminants. For example, drying a wet granulation would usually need a specification for moisture content to ensure the granulation is properly dried. A solution being adjusted to a certain pH would require a specification for pH. Specifications for weight, hardness, and thickness are typical for tablets during tablet compression. Encapsulation operations would require specifications for fill weight.

It is a requirement that you monitor in-process points, steps, or stages where control is necessary and be able to detect deviations that occur at those points. Deviations at the in-process control points should initiate an out of specification investigation to trace back to the root cause and determine if additional control points are necessary to ensure the batch is meeting all specifications throughout the manufacturing process.

Setting up in-process specifications can also be a beneficial business strategy in streamlining manufacturing operations so that the incidence of error is reduced. This can be done by using in-process specifications as checks to ensure that the manufacturing process is validated or identify where deviations are occurring and slowing down the manufacturing process due to having to re-work batches. Having to dispose or re-work product due to not meeting finished product can impact cost of manufacturing and reduce scheduled productions time creating back logs. In-process specifications maybe a requirement under 21 CFR part 111 but can prove to be a useful tool in manufacturing, packaging and labelling dietary supplements.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or