Good Pharmaceutical Manufacturing Advisory services

Pharma Manufacturing

The world of pharmaceutical manufacturing is one of the most governmentally regulated areas in the world. Existing on the same short list of activities that includes the nuclear power industry, transportation, and the stock markets; the legal structure that governs the development, production, and commercialization of drug products is both complicated and difficult to decipher.
PharmaConsult can provide experts who have extensive experience in both the writing of and interpreting the very laws and regulations that govern the industry today. We can provide insights into why specific decisions were made that will give you the “inside track” to meet your regulatory obligations.
Our focused approach will help you get to the answers you need as quickly as possible. We can either work with your teams to deliver a final resolution that will include training solutions for your team members or we can provide you with a complete ready to execute solution.

1. Active Pharmaceutical and Drug Product manufacture

From its earliest mention in the 1960’s until today, meeting the requirements of Good Manufacturing Practices (GMPs) has seemed like guesswork to many companies. With the general nature of the requirements in the US and the more specific requirements in the EU, there is still much interpretation in the application of the rules to pharmaceutical manufacturing processes. The recent number of warning letters from the FDA and the removal of hundreds of products from the US are sending clear warnings to the industry – COMPLY OR ELSE!

PharmaConsult Global is extremely knowledgeable and can identify, address and remediate potential problems that arise. We supply the “extra eyes” needed to see things differently and with our expert eyes, you will see more than you have ever seen before.
The GMPs for the manufacture of Active Pharmaceutical Ingredients (APIs) and Final Drug Products require a full system of Standard Operating Procedures (SOPs), procedures (e.g., receipt, sampling, and deviation investigation), and processes (batch records). We can help you create the systems you need for:

  • Quality,
  • Facilities and Equipment
  • Laboratory Controls,
  • Materials Receipt, Sampling, and Acceptance
  • Production,
  • Packaging and Labelling and
  • Post-Marketing Activities

We have experts with long standing relationships with some of the finest engineering firms in the pharmaceutical world and we can help design the perfect, lowest cost facility for your needs. But, once the products are manufactured, distributed, and sold; your job isn’t over because that’s you’re your post-marketing activities begin. Pharma Consult Global has the capabilities to interpret your activities and to confirm they meet the requirements in each of the major regulatory regions. We can work with you to develop the systems you need to create an environment for manufacturing compliance and profitability.

2. Biopharmaceutical Manufacturing Advisory service

The world of Biotech manufacturing shares many requirements with the requirements of API and drug product manufacturing Systems which must be in place for:

  • Quality,
  • Facilities and Equipment
  • Laboratory Controls,
  • Materials Receipt, Sampling, and Acceptance
  • Production,
  • Packaging and Labelling and
  • Post-Marketing Activities

However, within these requirements exist some very unique requirements more closely associated with aseptic, parenteral manufacturing than with the traditional API or Solid Oral Dosage Forms. And just because it is called a biosimilar, the standards for its production are exactly the same as for the innovator.

The most notable differences between the biotech/biosimilar facility and API or SOD drug product production can be seen in the facility which almost always gives the appearance of tightly controlled clean rooms in the biotech world. Surfaces and finishes must meet the demands of aseptic controls and be able to resist the harsh conditions required to clean and use the facility. Equipment is highly specialized, often located in ISO Class 5 environments.

Barrier operations may be visible and personnel are almost always gowned to prevent contamination of the product. HVAC systems must be designed to meet these requirements causing significant issues in themselves. Water supplies, always significant, must be clearly defined and closely monitored to confirm it meets the accepted standards in the country to which the product is being sent. It is not uncommon to use multiple sterilizing grade filters in the process and contact with product is always prohibited.

And so the issues go on. To begin production of a biotech/biosimilar production requires expertise previously found only in the major biotech companies and not available to the bulk of the pharmaceutical industry. Today that paradigm is changing but the knowledge that drives the biotech industry has not fully moved from large biotech to small companies. Our experts actually negotiated many of the Biotech documents in ICH and helped implement many of the changes in the FDA and EMA. We are investigators from the FDA with industry experience and trained reviewers who understand the required documentation that is needed to support product development, facility design, and registration activities. We have commissioned facilities and validated processes from beginning to end. We will bring our experience and knowledge to your company to help you design the processes you will need to move to commercialization. Our goal is to build a strong element within your company that can execute your plans to satisfy your needs as quickly as possible so as to not create a dependency on Pharma Consult Global. 

3. Sterile Product Manufacture

The most demanding of all the manufacturing processes is one of Pharma Consult GlobalX’s strengths. Aseptically processed, parenteral drug products require the highest level of attention and the well-trained staffs. They are unique in that even the minutest of contamination issues can ruin entire batches or even multiple batches. And yet, even today, we read of problems in the industry that are seemingly complex yet are, in actuality, a collection of simple problems. Our experts will be able to help you find the sources of your problems and create strategies that your personnel will be able to understand and perform repeatedly. We can help you evaluate your systems, your facilities and potential problems on the manufacturing floor. Your quality systems will be built to anticipate and resolve microbial and particulate contamination, equipment qualification, process validation, environmental mapping in the facility, and product disposition processes. Complex issues will become simple tasks, that when properly executed, can only lead to success in your manufacturing facilities. Your team will learn how to identify potential problems and quickly respond to real issues.

4. Good Manufacturing  compliance Auditing

PharmaConsult Auditing services will carry out the following;

  • We'll examine your manufacturing processes and submitted data
  • We'll carry out GMP reviews of manufacturing facilities and quality management systems
  • We'll audit your suppliers and contractors for compliance with GMP, GLP or other standards
  • We'll work with your QPs and other in-house QA experts to improve presentation of facility and systems for Inspectors
  • We'll prepare response documents or appeals on your behalf

The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient (ICHQ9)

Our experts have over 30 years’ experience in the multinational arena. We'll help you set up the right quality systems covering the entire product lifecycle. This includes everything from product development and manufacture through to packaging, labelling and distribution.

We specialize in;

  • Supply chain optimisation for worldwide distribution.
  • Lean manufacturing and six sigma optimisation and implementation of manufacturing and supply
  • Providing Qualified Person services for manufacture /importation.