Quality Management System (QMS)

Logidex has established a Quality Management System (QMS) to assure safety and effectiveness of manufactured products, customer satisfaction and conformity to mandatory regulations.



The quality program is developed to assure quality products and a conformance to the applicable laws and regulations, contract requirement and customers’ expectations.

Quality Manual

HIGHLIGHTS

Logidex has established a Quality Management System (QMS) to assure safety and effectiveness of manufactured products, customer satisfaction and conformity to mandatory regulations. This manual describes Logidex's Quality System Policies and Procedures. These policies and procedures control all activities from Supplier procurement to Customer shipment of products.

The quality program is developed to assure customer satisfaction by providing quality products. We will perform all activities in a manner, which meets or exceeds the expectations of our customers. The quality System described herein is mandatory for all activities performed at Logidex to assure product conformance to the applicable laws and regulations, contract requirement and customers’ expectations.

Logidex shall be working for increased satisfaction of all interested parties, including customers, personnel, suppliers, authorities and owners, by establishing their needs and expectations and by acting in a balanced way for fulfilling them.

We shall:

1. Sub-contract the manufacturing only to companies with a well-established quality system.

2. Only use high quality raw materials which are traceable to the original manufacturer.

3. Develop good relations to suppliers ensuring that the services do not compromise Logidex´ requirements and expectations.

4. Avoid involvement in any activities that would diminish confidence in our competence, impartiality, judgment or operational integrity.

5. Ensure that management and other personnel are free from any undue internal and external commercial, financial and other pressures that may adversely affect the quality of the work.

6. Have adequately educated and trained staffed.

7. Ensure compliance with all statutory requirements and regulations applicable to Logidex’ organization or the provided services.

8. Continually improve the effectiveness of the quality management system by periodical review.

REGULATIONS AND STANDARDS

The food supplements market is a regulated market. In Italy the regulations are issued in accordance with the European directives. The competent authorities are EFSA at European level, the Ministry of Health and AIFA (Italian Medicines Agency).

The food supplements’ manufacturers in order to operate need to be authorized by the local Councils (Regioni) according to Law 189/2012. The authorization is granted following the successful verification of the required hygienic and sanitary conditions and the technical requirements as per CE Regulations (CE) 852/2004 and (CE) 853/2004, art. 10 Legislative Decree 111/92.

Certifications recommended for manufacturers are HACCP, ISO 9001-2008, GMP.

Our products are categorized as Food supplement in the country of origin as per the current Law in Italy and Europe. For this category, the analysis of the identity and quantity of active ingredients are not compulsory, since they are not considered as drug/medicines.

Thus, the composition of the food supplement is verified by the manufacturer’s Quality Control (following the procedures established by the QMS), by, first of all, approving the raw material (considering the technical documents of the supplier, the appearance of the material, the history of the supplier…) and then by following an established procedure.

LOGIDEX – QMS

In Italy, the marketing of a dietary/food supplement can only occur after the product has been duly notified to the Ministry of Health, which is the competent authority to assess the correspondence of the formulation and the claims with current local regulations.

In case of a positive outcome the supplement, subject of the notification, will be included in the Register of dietary supplements available on the website of the Ministry and a Certificates of Free Sale will be issued.

All our products are duly authorized for sale.

Our manufacturers are authorized by the Ministry of Health to the production and sale of food supplements and adhere to the highest quality standards.

Our manufacturers possess the following certifications:

• GDP (CERTIQUALITY): CSQ ISO 9001:2008 & IMQ ISO 22716:2007

• HALAL CERTIFICATION: CERTIFICATE N.036-003-2014 REV.0

• BSE CERTIFICATION

• STABILITY: STANDARD STABILITY TESTS ARE PERFORMED INTERNALLY. ACCELREATED STABILITY TESTS ARE OUTSOURCED TO EXTERNAL LABORATORIES.

• ALL PRODUCTS ARE ACCOMPANIED BY A SAFETY DATA SHEET

• MICROBIOLOGICAL ANALYSIS IS PERFORMED ON EVERY BATCH

GENERAL REQUIREMENTS



Logidex has established a QMS and applies, updates, and maintains it according to the requirements of mandatory regulations.

Processes needed for the QMS, their sequence and relationship have been identified and defined. High level processes and their relationships are structured as the image.



DOCUMENTATION

QMS documentation established by Logidex includes:

• quality policy, objectives and manual (this document);

• QMS procedures (SOP’s);

• other operating product and process documents records.

The Quality Manual provides an “overall” description of the QMS, specifies the applications, includes reference to applicable mandatory regulations and to QMS procedures (SOP’s), provides a description of company processes and their relationship.

QMS procedures (SOP’s) describe and regulate (responsibility, execution, control and records) the processes established to implement and control the QMS.

Master procedures:

1. Quality manual and qualified person

2. Manufacturer qualification procedure

3. Distributor qualification procedure

4. Manufacturer management

5. Distributor management

6. Product shipment procedure

7. Complaints management procedure

8. Product traceability

Operating documents (such as material specifications, controlling operating procedures, etc.) define requirements and operating practices to execute / control a specific product) or a specific process.

Records provide evidence of performed activities or obtained results. More generally, records provide evidence of the implementation of QMS.

In addition to the documents listed above, Logidex has established and maintains the following documents.

Product dossier that is, for every finished product, the collection of documents (or their references) that define the product, its manufacturing process including development, tests, control methods, features and acceptance criteria.

Product History Record that is, for each lot, the collection of production records.

MANAGEMENT COMMITMENT

Logidex management, is directly involved in the implementation and maintenance of the QMS.

This commitment is expressed:

• by spreading within the company the awareness of the importance to meet customer requirements, company policy and guidelines, applicable regulatory requirements;

• through the definition of company quality policy and objectives;

• by monitoring and measuring processes to determine the level of satisfaction of the requirements and, more generally, of the client.

QUALITY OBJECTIVES

Logidex top management defines company objectives including quality ones and transfers to the operational levels (internal and external resources).

The objectives are evaluated and reviewed yearly to verify the achievements.

CUSTOMER COMMUNICATION

Logidex identifies and implements arrangements for communication with customers relating to:

• product information;

• inquiries, or order handling, including amendments;

• customer feedback, including customer complaints

RESOURCES MANAGEMENT

Logidex determines and provides in planned intervals, all resources needed to implement and improve the processes of the quality management system and to address customer satisfaction (including human resources, process equipment, utilities, etc). Evidences that required resources (in accordance with the requirement of customers and products requirements and organization development plans) have been provided are documented in the organization annual budget.

Personnel in all levels shall be aware of:

• Quality policy

• Quality management system requirements

• The importance of conformance with customer requirements, regulatory bodies, organization commercial partners and organizational requirements

• How they contribute to the achievement of the quality objectives

• The impact of their work in quality

• The benefits of improved performance

• Their roles and responsibilities in achieving conformance

• The potential consequences of departure from the specified procedures

Employees are trained, as necessary, to assure that suitable proficiency is achieved and maintained throughout our operation systems. Training is performed as "On the Job Training" under the direct supervision of management. Procedural changes are implemented by training of any individual(s) affected by the change.

MANUFACTURING

The subcontractors used for manufacturing are selected with care according to the Manufacturer Qualification procedure. The manufacturing is based on mutually agreed flows with subcontractors.

The manufacturer is responsible for the following:

• Maintain the Quality System certification GDP (CERTIQUALITY): CSQ ISO 9001:2008 & IMQ ISO 22716:2007

• Responsible for auditing to suppliers and contractors

• Inform of any change in the concerned product manufacturing, testing and delivering that may affect specifications or quality

• Specify work environment requirements and process utilities conditions in compliance with regulations and the registration files

• Implement incoming materials and finished product inspection and testing program as appropriate to assure that finished product meets specifications

• Perform routine monitoring and control on production processes according to the SOPs

• Responsible for releasing only the product which is conforming to established specification

• Responsible for manufacturer, packaging, labelling, storing and deliver products to the warehouse

MONITORING AND MEASUREMENT

Logidex has implemented the collection and monitoring of information relating to customer satisfaction as this also represents a way to measure the performance of the company QMS.

This feedback includes:

• customer complaints, if any

• information and data gathered during visits and contacts with customers.

AUDITS

In order to ensure proper implementation, functioning and effectiveness of the QMS and to see if the results are in line with expectations and with the QP, Internal Audits are planned and implemented.

The results of the checks are recorded and brought to the attention of the heads of the checked areas; the same undertake prompt corrective actions in relation to the identified weaknesses.

The Internal Audits have also the function of monitoring the implementation of the corrective measures taken upon findings occurred during the previous visits and determine the effectiveness of these actions.

Reports of Internal Audits are analyzed by the Management. The Internal Audits are carried out by the Quality Representative, if necessary with the use of checklists, to ensure the objectivity and systematic nature of the evaluations, or by following the instructions of the process.

The observations are recorded.

The Management may decide on further visits due to special needs.

CONTROL OF NONCONFORMING PRODUCTS

All personnel and the external providers have a duty to report and document the QSM about any NC detected during both the operating and the checking activities. All the QSM collaborators should be aware that the NC can be a useful tool for improvement, in fact, when analysed they allow to identify the causes and so predict the appropriate corrective action.

The detected NC are recorded on the NC Form. This form includes the following aspects: description of the problem (NC), correction (actions and responsibilities), communications, conformity audits after the correction, correction outcome.

The involved area is responsible for the correction decided and for verifying its effectiveness.

The correction may consist of:

• taking action to eliminate the detected nonconformity;

• authorizing the use, release or acceptance under concession by the relevant authority and, where applicable, by the customer;

• taking action to preclude the originally intended use or product application.

CONTINUOUS IMPROVEMENT

The continuous improvement of services offered to customers and of the quality management system is one of the primary goals of Logidex.

The organization will continually improve the effectiveness of the quality system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.

The goal of continuous improvement can be reached through the proper and effective management of corrective actions (CA), Preventive Actions (PA) and Improvement Actions (IA).