Validation, Design & Engineering


Dor’s validation, planning and engineering services help drug and medical cannabis manufacturers, medical device and accessories companies, logistics companies, hospitals and start-up companies to produce precise documentation in order to ensure that their facilities, equipment, systems, processes and instrumentation are in compliance with the requirements of international regulations.

Dor provides turnkey services to pharma and medical cannabis companies that are planning to establish manufacturing, extraction and packaging plants. Dor’s services include reviews of infrastructure gaps and economic feasibility analyses for projects. Dor advocates full transparency to customers, superior quality, professionalism and excellent service.

With the help of Dor’s comprehensive validation program, you will receive confirmation and written documentation that all components of your operations are producing high-quality results consistently every time, as is required by the registration regulations of the FDA, the European Union and other countries, in compliance with GMP (good manufacturing practices), GDP (good distribution practices, and GLP (good laboratory practices). Dor’s services are provided in conformity with 21 CFR 820, CFR Part 11, Procedure 126, Procedure 130, Procedure 135, ISO 9001, ISO 13485, GAMP 5 (Good Automated Manufacturing Practices).

Dor also helps organizations optimize their businesses by instituting corrective actions and preventive actions (CA/PA), thereby eliminating nonconformance at source, and by providing validation services using proven optimal methods that are customized to meet the customer’s needs – whether as a comprehensive solution or to help focus a project.

Dor’s validation, planning and engineering services include:

Obtaining initial approval and providing assistance in the design of a manufacturing and distribution facility

Analyzing and ascertaining whether existing facilities can be converted into facilities for pharmaceutical and medical cannabis manufacturing

Building and assimilating GMP-certified quality systems, drafting of work procedures, supervision and the performance of full validations and the drafting of protocols

Performing preliminary inspections, attendance during the approval of the facility and providing assistance until the facility is certified by the Ministry of Health

Conceptual and functional planning of production plants

Performing validations, including design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)

Performing validations of computerized equipment, software and computer system validations (CSV)

Drafting plans for the Ministry of Health (Institute for Audits and Standards for Medical Substances) and the Medical Cannabis Unit

Drafting URS's for production plants and stores

Defining requirements for production machinery

Performing validations and qualifications for production machinery, equipment and plant systems

Performing qualifications for clean room HVAC systems

Planning validations, developing validation master plans and writing site master files and planning production processes

Performing and supervising validations of the cleanliness of production machinery

Performing trial runs of production processes and validating them, drafting dose/batch sheets, reviewing the batch documentation and drafting various production methods

Performing summer and winter validations for medical cannabis and drug warehouses

Performing validations for processes, including dry and wet products

Preparing and drafting product files according to Ministry of Health procedures

Providing temperature and humidity mapping services, drafting a mapping protocol, performing the mapping using temperature and humidity collectors, drafting of reports and issuing recommendations

Providing training on GMP and GDP topics and providing a full review of the validation process

Validating medical devices – fast track for the US FDA (21 CFR 820), CE marks of the European Union and approval processes of ISO 13485:2016


Why Us


לייק

Get pragmatic and creative solutions from specialists with a wealth of validation experience

Dor professionals are seasoned experts with intimate validation knowledge from years of experience in clean room processes, systems and equipment, as well as production, storage, distribution and transportation.

טיימר

Forward-looking expertise

Dor has its finger on the pulse of emerging regulations to help you remain in compliance over the long term.

רופא

Empowering customers to promote independence

Dor prides itself on truly listening to customers, understanding their vision, needs and concerns – and customizing solutions to each situation. With results-oriented projects, Dor’s goal is to help organizations strengthen and broaden their capabilities so they can function on their own.

לוח

A customer-focused approach to overcome regulatory barriers

Dor helps organizations gain peace of mind that they are in control and in compliance, seeing regulatory requirements as necessary quality steps, and not daunting, insurmountable hurdles. The Dor team has helped organizations exceed Ministry of Health requirements, earning three-year review cycles instead of biennial reviews.