Introduction

Subpart D² of the Code of Federal Regulations is dedicated to equipment. 21 CFR 211.63 deals with design issues, 211.65 with construction, 211.67 and 68 deal with maintenance, cleaning, and automation. The one remaining section 211.72, deals with filters, types (no fibers), and uses. All of these are critical to assuring that the production of the product(s) remains in control and that they are consistent in identity, strength, quality, and purity.

Some consider equipment and utility qualification to be part of Stage II,³ however, for our purpose it is included in Stage I. In reality, it does not matter in which stage it is included as long as it is completed prior to the execution of the process validation. The process cannot be validated unless all of the support utilities and the process equipment have first been qualified.

If the Active Pharmaceutical Ingredient (API) is known, then the manufacturer obtains it from a qualified vendor. If the API is not known and needs to be developed, the R&D department screens compounds and selects the most likely candidate (see Chapter 4: Getting Started). Once the moiety has been selected as a promising drug candidate the formulation team and process engineers begin their planning. The formulation department plans the means of the drug delivery (eg, tablet, parenteral, cream), the engineers take the information on the chemical and physical nature of the product and determine the equipment type to be used. That is, they are told the process needs (eg, blending, granulation, mixing, etc.). Marketing and the process group then determine the batch size needed. With this information the process engineers then work out the specifications for the equipment. This information is known as the user specifications or user requirements. The user specifications are then submitted to the vendors and bids are obtained.

Stay updated, free articles. Join our Telegram channel

Join