The Indian pharma industry expects the US FDA's recently released SUPAC (scale-up and post-approval changes): Manufacturing Equipment Addendum will further give fillip to faster clearances in plant audit and product approval. After releasing the Addendum, the US regulatory authority is seeking comments from the pharma industry before June 30, 2013.

India already has over 170 US FDA approved units and has bagged 178 Abbreviated New Drug Applications (ANDAs) in 2012 which is over 34 more than the 2011. These include companies from Aurobindo to Biocon, Dr Reddy’s Labs, Lupin, Sun, Indoco Remedies, Ranbaxy and Strides Arcolab. Now with a strong focus for generic drug prescriptions from the governments of US, European Union and Japan, there are many Indian companies exporting to these markets. Therefore the new draft guidelines on scale-up and post-approval changes: Manufacturing Equipment Addendum will only strengthen compliance to the global regulator’s requirements, said representatives from pharma industry.

The draft guidance combines the scale-up and post-approval changes for industry for the immediate release and modified release solid oral dosage forms and non-sterile semisolid dosage forms. It removes the lists of manufacturing equipment that were in both guidance and clarifies the types of processes being referenced.

Therefore the current draft SUPAC addendum should be used in conjunction with the earlier one as it includes the chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, apart from in-vitro release testing and in vivo bioequivalence documentation, stated the regulatory authority.

The SUPAC guidance defines the levels of chemistry, manufacturing, and control change recommended for each level of change for a new drug application and abbreviated new drug application.

The draft SUPAC addendum, together with the SUPAC guidance, is intended to help the manufacturer, determine the documentation to submit to FDA regarding manufacturing equipment changes.

When the SUPAC equipment addenda were published with tables referencing specific equipment, the tables were misinterpreted as equipment required by FDA. Now the regulator recognises that scientific innovation and technology advancement are commonplace and play a significant role in pharmaceutical development, manufacturing, and quality assurance. “We are concerned that such a misunderstanding could discourage advancements in manufacturing technologies. Therefore, this revised draft SUPAC addendum contains general information on SUPAC equipment and no longer includes tables referencing specific equipment. It  also includes changes to clarify the types of processes being referenced,” said the regulatory authority.

The information is presented in broad categories of unit operation. For immediate or modified release solid oral dosage forms, broad categories include blending and mixing, drying, particle size reduction/ separation, granulation, unit dosage, coating and printing, and soft gelatin capsule encapsulation. For nonsterile semisolid dosage forms, broad categories include particle size reduction and/ or separation, mixing, emulsification, deaeration, transfer, and packaging. Definitions and classifications are provided. For each operation, equipment is categorized by class operating principle and subclass design characteristic. Examples of types of equipment, but not specific brand information, are given within the subclasses.

When assessing manufacturing equipment changes from one class to another or from one subclass to another, the manufacturer can follow a risk-based approach that includes a rationale and complies with the regulations, including the CGMP regulations. We also recommend addressing the impact on the product quality attributes of equipment variations via process parameter) when designing and developing the manufacturing process, stated the regulatory authority.