QUALITY UNIT

Standards ensure quality and smooth processes

Quality Unit2

Nowadays, customers take the highest quality standards for products and processes as a given. Rottendorf’s management team has committed to act accordingly. Our Quality Unit enables us to maintain our high-quality level by applying a standardized quality management system and through regulatory support during all phases of the product life cycle. In addition, regulatory compliance, continuous improvement of all quality systems, and batch release are further tasks of the Quality Unit.

QUALITY ASSURANCE

Achieving Full GMP Compliance


At Rottendorf Pharma we understand the increasing complexity of regulatory requirements. Through our experienced Quality Assurance team we offer all required functions to always achieve full GMP compliance:

REGULATORY SUPPORT SERVICE

REGULATORY INSPECTIONS EVERY YEAR

QUALIFIED PERSON RELEASE

CLEANING VALIDATION STUDIES

SUPPLIER & CONTRACTOR QUALIFICATION

ANNUAL PRODUCT QUALITY REVIEW

REGULATORY SUPPORT SERVICE
Page 1
Group 24
Group 23
Group 22
Group 21
Group 19
Group 18
Group 16
Group 14
Group 12
Group 9
Group 8

QUALITY CONTROL

The Integrity of the Product Counts

Rottendorf Pharma provides all the analytical capabilities you need for outsourced manufacture and development of solid oral dosage forms. To fulfill our commitment as a full-service contract development and manufacturing organization, we support a large analytical department staffed with experts to meet your needs for outsourcing.

"To fulfill our commitment as a full-service contract development and manufacturing organization, we support a large analytical department staffed with experts to meet your needs for outsourcing."

Analysis

Release analysis of starting materials

Validation

Validation of new and existing methods

Development

Analytics supporting development

Analysis

Analysis of stability studies

Transfer

Transfer of analytical methods

Methods

Development of new analytical methods

Analysis

Release analysis of finished products

Studies

Performance of stability studies

Methods

Optimization of existing analytical methods

QUALIFIED PERSON

An important integral function

The concept of the qualified person according to EU regulations is different from regulatory aspects in the US or in any other state outside of the European Union. The personal responsibility and liability of the QP is a very specific requirement. Each Qualified Person needs to be registered with and appointed or approved by the competent authority of the EU member state in which he or she is operating. Not only the pharmaceutical company for which he or she is acting, but also the registered qualified person themselves is responsible for his or her duties.

>


Qualified Person, Quality Unit

"For Rottendorf Pharma GmbH the QP function has a fundamental function within the Quality Systems. The QP is also an integral part of the manufacturing license and is personally approved by the District Government of Muenster, focusing on quality evaluation and release function."

"The QP at Rottendorf Pharma GmbH as a multinationally operating CDMO also has to make sure that all customers' related quality aspects are respected as defined in the approved Quality Agreements and internal Quality procedures – especially against the background of the different country requirements."

Kupferberg1

To enable the QP taking over these responsibilities he or she is directly involved in all quality-related decisions for products and batches including upcoming changes. In-depth knowledge of products, processes, systems and procedures along with experience are keys in making adequate and effective decisions with regard to products, customers and patients. Personal qualification with regard to the legal requirements is a starting point but needs to be continuously expanded with day-to-day operational experience, process understanding, and regulatory knowledge.

  • Release of commercial batches and clinical trial batches using one QMS
  • Release for shipment vs. release to market
  • Release of medicinal products and test products on to the market in adherence to the Regulations of § 16, subsections 1 to 6 of the AMWHV and for imported medicinal products to the regulations of § 17, subsections 1 to 3 of the AMWHV.
  • Batch certification according to EU-GMP-Guide Annex 16
  • EU-release for imported drug products
  • EMA QP declaration on APIs
  • Auditing of API manufacturers for regulatory purposes
  • Ensuring that retention samples are stored from each produced batch of a finished medicine in accordance with the provisions of § 18, subsection 1 of the AMWI-IV as well as from each batch of starting materials used for the production of medicines in accordance with the provisions of § 18, subsection 2 of the AMWHV
  • Ensuring that enough samples are stored from all testing materials and their labels and printed packaging materials in accordance with the provisions of § 18, subsection 3 of the AMWHV
  • Controlling of the fulfillment of the requirements of subsection 8, enclosure 16 to the EU GMP Guidelines:
  • Ensuring that all papers confirming the compliance of each batch with the regulations of the AMG and the AMWHV are recorded in a consecutive register
  • Ensuring that contracts have been concluded with contract manufacturers and contract laboratories
  • Ensuring that a QM system has been established and is being implemented at Rottendorf Pharma GmbH
Kupferberg3

The QP at Rottendorf Pharma GmbH as a multinationally operating CDMO also has to make sure that all customers' quality considerations are respected, as defined in the approved Quality Agreements and internal quality procedures – especially against the background of the different country requirements. For that reason he or she is also directly involved in establishing Quality Agreements and maintaining the agreed status.

Total Process Ownership (TPO) as our company philosophy is also applied to the QP services. The QP contributes in providing optimal service for our customer by bringing in his or her competence, expertise and experience.