A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow for continued packaging operations during construction and qualification activities.… more
A client contacted Performance Validation requesting assistance with commissioning of a pediatric research center renovation project. The research center was to be located within a renovated 2nd floor of an old building that is part of a children’s hospital and was to include exam space for patients participating in clinical research programs as well as space for research labs, lab support, offices, and staff support. … more
In a recentlyposted warning letter to a Chinese drug manufacturer the FDA identified a specific violation citing the Jan 2011 FDA Guidance to process validation.
Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).… more
The initial Guidance for Industry cGMP – Interim guidance was issued July 2014 and a link to this document is available here. A total of 25 comments were received from various organizations which are available for viewing here. … more
One of the key elements supporting commercial manufacturing of pharmaceutical or compounded products is the facility design. This element is captured in the Drug cGMPs as subpart C Buildings and Facilities, and codified in 21 CFR 211.42 Design and construction features.… more
FDA has issued the Data Integrity and Compliance with Drug cGMP final guidance on December 13, 2018. The final guidance is available at the following link.
As stated in the Introduction section of the guidance:
FDA expects that all data be reliable and accurate (see the “Background” section).… more
In a recently posted warning letter, the FDA identified significant data integrity issues associated with electronic data logs for production equipment and laboratory records.
This citation was based on:
A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems:
Performance Validation (PV) developed and executed the applicable commissioning, installation, operational, and performance qualification deliverables to ensure that all the systems included in our scope were installed and functioned as required by the client and per vendor recommendations.… more
Are you a 503B trying to understand the FDA Regulation and Inspection Guide? Do you feel like these guys?
I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356.002) Drug inspections.… more
As reported by the Pew Charitable Trust, Feb 26. 2018: