By HAPILA GmbH
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HAPILA Quality Management Systems
HAPILA GmbH runs an Integrated Management System that meets the international quality standards of ISO 9001, ISO 14001 and ISO 45001 as well as Good Manufacturing Practice (GMP) standards in relation to production, quality control and release of Active Pharmaceutical Ingredients (APIs).
Together, these quality assurance standards underpin the quality of the pharmaceutical products expected by HAPILA customers from all business units as well as ensuring the company meets its strategic objectives.
HAPILA’s QM policy is based on the principle that each work step not only contributes to the quality of the final product but also needs to have inherent quality in and of itself. This requires an overall environment that emphasises appropriate technical and organizational equipment as well as qualified personnel.
HAPILA GmbH is issued active ingredient-specific GMP certificates by the relevant competent authority, the TLV Thüringer Landesamt für Verbraucherschutz / Thuringian State Office for Consumer Protection). These allow HAPILA to produce pharmaceutical ingredients in compliance with the terms of the AMWHV (regulation governing the manufacture and distribution of pharmaceuticals) as well as testing, storing, packaging and distributing these substances.
The point of starting the GMP manufacturing of an API will be justified and documented within the manufacturing description. For synthetic processes, this is the point at which source material is inserted into the process that will be used for the manufacturing of an API and inserted into the structure of the API as an important structural element. From the moment where starting materials are included in the process, appropriate GMP measures have to be used for all subsequent intermediate and/or API manufacturing steps including the physical processing of API. This includes the validation of critical process steps determined to have an influence on the quality of the API.
The process must document each deviation of a manufacturing, sampling, testing, packaging, shipment or cleaning instruction of raw materials, intermediates or finalized active pharmaceutical ingredients starting with the stage of the regulatory starting material and also of qualified and validated procedures and systems. Major and critical deviations need to be examined systematically and documented.
A formal change control system governs assessment of all changes that could have an influence on production and the control of an intermediate or an API. All proposals for GMP relevant changes are written down, reviewed and approved by the responsible organisation units and also by the quality unit. The potential risks of the proposed changes to the quality of the intermediate or API have to be evaluated. The changes can be classified depending on the type and extent of the change and also on the extent of the impact to process.
QMS aligned to GMP
By implementing a quality management system with its supporting structures, HAPILA has incorporated GMP (Guideline of Good Manufacturing Practice part II) and its legal stipulations (Ordinance on the Production of Pharmaceuticals and Active Substances AMWHV) into its operations.
As the demands on quality management increase with the progression of a project, these are verified by the Q functions to which qualified employees have been assigned.
HAPILA’s QM system is described in detail in its quality assurance manual. The management of HAPILA GmbH enforces those measures described in the manual, according to clearly defined responsibilities. Quality in the company is achieved in accordance with the following principles:
- Responsibility of the management
- Motivation and involvement of the employees
- A process approach.
These core principles are designed to ensure provision of services and products of the highest quality, along with compliance with legal requirements regarding environmental protection, safety and security for personnel and equipment as well as all relevant pharmaceutical guidelines.
Implementation of these principles is supported by a QM documentation system relying on broad-based Standard Operating Procedures (SOPs) that describe all processes determining and impacting on quality. These include:
- manufacturing, sampling, testing, release, packaging and shipment according to approved instructions
- qualification of supplier, contractors and transport companies
- qualification of facilities and equipment
- validation of manufacturing, cleaning and testing procedures
- personnel training
- change, deviation, OOS and CAPA management.
The quality unit is responsible and performs the tasks of quality assurance and quality control and is to be consulted on all quality related themes and also responsible for reviewing and approving all quality relevant documents. The management is involved in quality management in manifold ways. There is a continuous review of the quality management system to ensure the effectiveness and efficiency of the QM system and to continuously improve the system.
HAPILA DIN ISO certification
HAPILA GmbH also recently secured DIN ISO certification for its installed Integrated Management System from the TÜV Thüringen e.V. (Technical Supervision Association Thuringia). This confirms HAPILA as meeting the standards DIN EN ISO 9001:2015 for Quality management systems (QMS), as well as DIN EN ISO 14001:2015 Environmental management systems (EMS) and DIN ISO 45001:2018 Occupational Health & Safety (OHS) management systems.
The DIN ISO certification covers HAPILA’s GMP compliant development, manufacturing and distribution of active pharmaceutical ingredients (APIs) as well as reference substances and APIs for In-vitro-diagnostic products and/or clinical samples.
The certification audit focused on the main ISO quality management principles: customer focus, leadership, human engagement, process approach, improvement, evidence-based decision making and relationships management. HAPILA passed with no deviations. Further annual surveillance audits will verify continued effectiveness and adequacy of installed procedures and systems.
DIN ISO certification allows HAPILA combine GMP requirements for API manufacturing, verification and release with the requirements of the international management system standards ISO 9001, 14001 and 45001 in one Integrated Management System that can control all processes within the company. This means HAPILA can also meet the needs of customers who may not require cGMP manufacturing but definitely demand high levels of assured quality, especially when it comes to reference substances and APIs for In-vitro-diagnostic products.