QP / Quality Assurance

It is important to know that GMP, GDP and ISO requirements are not regulated procedures but general guidelines that every organization needs to comply with as it sees fit and the nature of activities carried out. There are many ways in which these requirements may be implemented, and it is the organization’s responsibility to determine the most effective way to create this into a high quality process. Ultimately, a proper quality system must ensure the quality of the medical product in order to safeguard its consumer’s health.
It should be emphasized that the Health authorities such as the FDA and the Israeli Ministry of health conduct regular audits for suppliers of health services such as manufacturers, importers, drug warehouses and laboratories, and if significant impairments are found, sanctions or even legal procedures for stopping business activity may be imposed until the impairments are corrected.
Blau Pharmaceutical Services provides pharmaceutical and medical device companies services based on vast theoretical and practical knowledge in the quality and QC fields, high professionalism, high flexibility to changes, uncompromising quality of performance, and assists our clients to benefit from our experience and withstand high standards set by the health authorities.

Ministry of Health requirements of manufacturers and importers of medicines and medical devices in the quality field

  • Manufacturers/importers and drug warehouses – managing a quality system that complies with standards of the Pharmacists’ Regulations (Good Manufacturing Practice) and the Ministry of Health procedures.
  • Manufacturers/importers and drug warehouses – managing a storage system that complies with the requirements of good storage practice, and a distribution system that complies with the requirements of good distribution practice.
  • Importers/registration holders of medical devices – managing a quality management system according to the standards of Israeli standard ISO 9001 : 2008
  • Manufacturers of medical devices – managing a quality management system that complies with the ISO 13485 standards
  • Tracking the quality performance of medicinal products
  • Evaluation of suppliers
  • Evaluation of the quality system of the organization
  • Conduct according to official procedures determined by the organization and the Ministry of Health procedures
  • Potential risk evaluation concerning quality, safety and efficacy of medicinal products
  • Quality control to ensure supply of products complying the specifications
  • Management of a system capable of recalling any final product from the shelf and the supply system

QP (Qualified Person) Services that we supply

Peter Blau CEO of BLAU Pharmaceutical Services has been handling batch releases of medicinal products to the Israeli market and to markets outside of Israel for more than 20 years. Peter Blau’s has vast experience in the release of hundreds of batches for the leading manufacturing company Teva. In the past years for many medicine importers. Together with the professionalism of the company employees and their proven methods of work Blau Pharmaceutical Services will enable you to be sure that this critical activity is performed according to the Ministry of Health requirements and your expectations.

We are aware that the responsible pharmacist is the central link in the process of supplying medicinal products at the required quality in order to maintain the safety in the patients, and its success is dependent on maintaining an excellent working relationship with the manufacturers, drug warehouses, transporters and of course, the inspection unit of the Ministry of Health.

As your partner, you will receive, amongst other things, the following services:

  • Regular or temporary filling the role of responsible pharmacist (QP)
  • Regular or temporary performance of the activities of the responsible pharmacist, according to your needs
  • Release of medicinal products batches listed at the national medicines registry of Israel
  • Release of experimental products batches for clinical studies
  • Release of unregistered products imported according to procedure 29
  • Improvement of the interfaces between the responsible pharmacist and the appointed pharmacist, the management, the Ministry of Health and the drug warehouse

QA (Quality Assurance) Services that we supply

Blau Pharmaceutical Services has profound familiarity with international management systems such as GMP (good manufacturing practice), GSP (good storage practice), GDP (good distribution practice), ISO, on a theoretical level as well as on a practical level. Our expert experienced staff provides a variety of solutions to the challenges that manufacturers and importers of medicines and medical devices face in the quality field.

Medicinal products (medicines) field:

  • Founding a quality system according to the requirements of the Ministry of Health in order to obtain a manufacturer/importer certificate
  • Upgrading the quality system of the organization in order to comply with the most up to date requirements of the Ministry of Health
  • Preparation for the Ministry of Health’s GMP audit (medicine importers, drug warehouses)
  • Writing new procedures and updating existing procedures according to the requirements of the authorities and manufacturers abroad
  • Preparation of documents: quality agreement with subcontractors (such as manufacturer, drug warehouse, transporters, labs etc.)
  • Conducting quality audits(GMP, ISO) for contractors / suppliers – in Israel and recognized countries
  • Qualification of suppliers
  • Performing critical activities of the quality system of pharmaceutical / medical device companies, such as:
– Discrepancies, customer complaints, corrective action and preventative action (CAPA)
– Control of variations
– Training / qualification
– Management of suppliers
– Management review
– Internal and external quality audits
– Potential risk evaluation
– Process quality controls
– Monitoring the performance of the annual work plan including documentation (Good Documentation Practice)
– Annual product quality review
  • Regular updates regarding changes in the quality requirements of the authorities in Israel and internationally

The medical device field:

  • Preparation for the 2008 Israeli standard: ISO 9001 audit, supporting the organization during the audit up to receiving the standard
  • Preparation for the ISO 13485 audit, supporting the organization during the audit up to receiving the standard
  • Preparation for the ISO 27001 audit (information security), supporting the organization during the audit up to receiving the standard
  • Preparation for the ISO 27799 audit (information system security in the health field), supporting the organization during the audit up to receiving the standard
  • Supervising and monitoring the quality system regularly after receiving the standard
  • Support in determining the quality policy, quality goals and preparing an action plan to achieve them
  • Preparation of quality processes across the organization, improving quality controls in order to receive a product that complies with the determined specifications
  • Preparing a work plan to achieve constant improvement in the quality system

In conclusion,Blau Pharmaceutical Serviceswill provide you with a perfect solution tailored to all of your organization’s quality needs!