Packaging Line Qualification

The Challenge

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


Hospital Building Commissioning

The Challenge

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


Process Validation

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


Comparison of FDA cGMP Compounding Guidance

Comparison of FDA cGMP Compounding Guidance.

Background:

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


Facility Design

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


Data Integrity Final Guidance

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


Data Integrity Remediation

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:

  • The firms electronic data logs not retaining alarm messages indicating when certain manufacturing parameters exceed their limits during production operations. 
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Greenfield Capital Expansion Project

Challenge

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:

  • Compressed Air Generation and Distribution
  • Nitrogen Distribution
  • Process Alcohol Distribution
  • Plant Steam Generation
  • Pure Steam Generation and Distribution
  • Vapor Compression Distillation Pretreatment Unit
  • Two (2) Vapor Compression Distillation Units
  • Cold Water for Injection Distribution
  • Hot Water for Injection Distribution
  • Purified Water Distribution
  • Drive-in Refrigerator
  • Three (3) Walk-in Refrigerators
  • One (1) Walk-in Freezer
  • One (1) Drive-in Freezer
  • Two (2) Reach-in Freezers
  • Ten (10) Air Handling Units
  • Three (3) Facility Management Systems

Solution

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


FDA Regulation and Inspection Guide

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


PEW Report – State Oversight of Drug Compounding

As reported by the Pew Charitable Trust, Feb 26. 2018:

  • The Pew Charitable Trusts’ drug safety project has identified more than 50 reported compounding errors or potential errors from 2001 to 2017 linked to 1,227 adverse events—undesirable experiences associated with the use of a medical product—including 99 deaths [bold added by author].
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