No pharmaceutical manufacturer want to undergo a Food and Drug Administration inspection, but these checks are a routine part of maintaining compliance with regulatory standards. What companies want to avoid is a Form 483, which inspectors use to document problems. Complicating the matter is a new FDA “quality metrics” initiative, which the agency is pursuing […]
As more pharmaceutical companies are born, so are stricter guidelines regarding adequate process control. Media fill runs refer to a required demonstration by a pharmaceutical company that accurately and efficiently performs and showcases controlled processes. Some of these guidelines include cleaning and disinfectant protocols, environmental monitoring, and equipment and process simulations.
One of the most important […]
For over 15 years, PharmEng’s consultants have been successfully guiding clients safely through all commissioning and qualification issues according to their specific needs. Serving manufactures of health products, PharmEng has the experience and knowledge to help businesses in this industry know how to execute commissioning and qualification requirements.
Within the health care industry our clients come from:
Biotech / […]
Consultants Responding in Form 483s, Warning Letters Offers Drug Makers Insight on FDA Enforcement Trends
Pharmaceutical manufacturers might be interested to know that Food and Drug Administration inquiries have led to fewer enforcement actions. The agency Office of Prescription Drug Promotion issued just nine warning and untitled letters during 2015, an all-time low, according to the Eye on FDA blog. In the context of recent years, the 2015 figures suggest […]
In residential facilities finding mold is a sign of a larger problem; issues with building materials, structural flaws, water leaks, environmental instigators, to name just a few. In the pharmaceutical industry, discovering mold can lead to the discovery other system or facility issues and must be dealt with in a professional and expedient manner.
Not only […]
Why do you need how to perform aseptic simulation in the pharmaceutical industry? Here are 3 reasons.
You need to know how to perform aseptic simulation testing because it is the pharmaceutical industry’s standard testing process for new pharmaceuticals. Since it is a standard test, many agencies have attempted to standardize the procedure to make it more uniform.
Regulations and guidelines have been revised and painstakingly documented. Unfortunately these attempts at standardization have only served to cause more confusion, “especially […]
When it comes to making sure that pharmaceutical manufacturing complies with regulatory requirements, the size of the company can make a difference. Large companies span their operations across multiple sites, which makes it difficult to implement and maintain uniform procedures companywide. But enlisting the expertise of FDA compliance leaders in the pharmaceutical industry can ensure that […]
Integrating up-to-date training programs for all areas of business is essential for a company’s overall success. PharmEng Technology provides international consultation and training for all essential aspects of healthcare industry compliance, including regulatory affairs. With the help of the proven expert training staff PharmEng employs, companies can manage the skills of personnel and meet the […]
Three words that have been in the pharmaceutical industry for years are Standard operating procedure (SOP). These procedures control the steps someone takes to produce a product. An SOP can usually be written by anyone who has knowledge of the work flow.
Consent decree services are becoming more important in the pharmaceutical industry. Earlier this year […]
Gaining a clear perspective of your company’s objectives concerning how to execute commissioning and qualification is vital in the highly regulated industries the customers we serve operate in. PharmEng Technology provides clarity to those we serve in navigating these matters in a timely and cost efficient manner. Our experienced consultants know the current global regulatory requirements and […]