Einstieg

Documentation & Validation for
the Pharmaceutical Industry

Documentation & Validation

We consider planning and implementation of processes and systems for the pharmaceutical solids production a benefit for our customers. Not only in the field of machine technology, but also in project management, technical documentation, and qualification, we aim to present our customers with the best results.

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Documentation & Validation
by L.B. Bohle

Qualification
L.B. Bohle implemented a validation master plan for the definition and implementation of qualification measures and the resulting further processes. The life cycle based on the V model is the basis for all documents here.
The Bohle Validation Plan (BVP), a generic document that is used for all projects and processes is distinguished from the project-specific document Bohle Validation Project Plan (BVPP).
The BVPP is project-specific and defines the individual project milestones, the deadlines for document transmission and the time period available for the customer to review the documents. The BVPP is created by the competent project manager in cooperation with the responsible departments (construction, electronics, software, and documentation) in coordination with the customer and approved by the latter.
The BVP is applied in all qualification-relevant processes and is divided into the following main areas:

  1. Qualification: with definitions, responsibilities, and detailed instructions for implementation
  2. Deviation management: including definitions, responsibilities and detailed instructions for handling deviations during qualification
  3. Change management: Instructions for the correct documentation of changes to qualified systems

Qualification at the customer’s site is generally carried out by an L.B. Bohle service technician or commissioning engineer. In the case of plug-in systems or systems that are no longer significantly dismantled for transport, the qualification can also be carried out directly by L.B. Bohle.

Documentation
L.B. Bohle prepares the machinery and plant documentation in accordance with the machinery directive 2006/42/EC.
Due to the close cooperation with the project management, project- or customer-specific requirements are directly implemented during the preparation of documentation.
The use of an editorial system ensures the consistently high quality of the documents. Furthermore, L.B. Bohle uses translation software. A large number of languages can be implemented in cooperation with external translation agencies.

Ansprechpartner

Your contact for Documentation & Validation

Peter Gammersbach

Technical documentation / validation officer
E-Mail
+49 2524 – 93 23 715

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Potential subjects of interest

Service Center

At our Ennigerloh headquarters Service Center, our customers can test our machines for all process steps of pharmaceutical solids production and optimize their processes.

Your product tests with us

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Machines & processes

Product efficiency increase is the central benefit of L.B. Bohle. To this end, we offer both complete production plants and solutions for individual production steps.

Go to our Machines and Processes

Contact

We look forward to hearing from you!

+49 (0) 25 24 93 23-0
info@lbbohle.com

Go to the contact page

Contact

We look forward to hearing from you!

+49 (0) 25 24 93 23-0
info@lbbohle.com

Go to the contact page