How to become Quality expert

[Milena (Milena Mikulić)]

Hello.

I have 9 years of expirience in pharmaceutical industry (Regulatory Affairs) and I would like to switch my career in QA department. Can somebody give me some advice which would be my first steps in order to became Quality expert? From where should I begin? I have faced with Quality department many time as it is connected to RA.
Thank you.

[sunilrbudhkar]

Quality Assurance and Regulatory functions are complementary to each other. Therefore your experience in the Regulatory department would be useful in Quality Assurance.
This is because there are specific Regulatory requirements which must be complied by the pharmaceutical manufacturer on continuous basis right from registration of new products and covering entire life cycle. QA function ensures that Regulatory requirements are comlplied on continuous basis while manufacturing, storage and distribution of the drug products. This is achieved through establishing Quality Management System (Pharmaceutical Quality System) in the organization.

Therefore, please read GMP related guidelines and get yourself acquanted as follows,

The Drugs & Cosmetics Act 1940 & Rules thereunder 1945 (Schedule M for GMPs)- India
ICH Q7 - GMP of APIs
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System
ICH Q12 - Life cycle Management
21 CFR part 210, 211 -GMPs as per USFDA
Eudralex volume-4 GMPs as per European Rgulations (EMA)
WHO GMP guidelines
(Besides above there are country specific GMP guidelines)

“Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those such as product design and development.

“Good manufacturing practice” (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: crosscontamination (in particular of unexpected contaminants) and mix-ups (confusion).

Additionally, there are certain softskills to be developed by QA person, such as,

• Good communication skills (both written and oral)
• Conflict handling ability
• Patience
• Convincing power with appropriate scientific or technical judtification / supporting reference / Regulatory requirements.
• Analytical skills and decision making ability (Required for conducting internal audits)
• Training skills (Training to the employees)
• Leadership (to establish Quality Systems and implement throughout the organization, Leading clients’ audits and Regulatory inspections)

[sunilrbudhkar]

You are always welcome.