- Implementation of Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are a set of appropriate practices that may ensure the quality and uniformity of manufactures products from laboratories and processing plants. This practices are mandatory.
Having the certification allow the laboratories or processing plants to ensure the manufacture of product with quality by offering processing services that comply with national or international sanitary requirements.
1.1 Diagnosis and Development of an Implementation Plan (suitable for all operative areas).
Identification of the organization needs and status versus current sanitary requirements. Design of a plan to address pending issues in accordance with GMP standards.
1.2 Permanent technical support, development of plans and working programs
Preparation of working plants with objectives, responsible and schedule that will be a tool to control the proper implementation.
1.3 Document control, procedures, manuals, records and training
Knowing that GMP has an important support from documents, our services includes the preparation of a proper document control, according with the type of organization and its needs. This will ensure that all of what is stated on the GMP is reflected properly and effectively. The service also includes the development of continuous training programs for technicians and workers with the purpose of making them aware of GMP requirements, and those of their work..
1.4 Design, infrastructure, equipment and adjustments in accordance with requirements of sanitary regulations.
Evaluation of the best and most suitable options of equipment and infrastructure that will ensure the development of processes and operations under quality conditions.
- Implementation of Good Storage Practices (GSP)
Good Storage Practices are design to ensure the maintenance of products quality features. When implemented the organizations add value to their storage operations, for their products and the storage services that they may offer
2.1 Diagnosis and Development of an Implementation Plan.
In accordance with the type of products and the facility, the status is defined to align it with current GSP requirements, combining diligent operations and sanitary requirements. The service considers permanent technical support, development of plans and working plans.
2.2 Document control, procedures, manuals, records and training.
Client guidance to elaborate and to adequate procedures, instructions, records, formats and all related documents, which demonstrate compliance with GSP. Also we will offer training to personnel in order to ensure that their performance is suitable with sanitary requirements.
2.3 Preparation of a GSP Manual.
When the procedures and record preparation and review are finalized, the client receives an outline of all these documents under the format of a GSP Manual, which gathers the required sanitary conditions and serves as reference for the facility operative activities.
- Implementation of Good Laboratory Practices (GLP)
Good Laboratory Practices allow to ensure that the results obtained by a laboratory are reliable and of quality. Having this certification guarantees the quality of the tests and analysis conducted to products.
3.1 Diagnosis and development of an implementation plan.
Analysis of product analytical requirements. Permanent technical support in the development of analytical techniques and technical specifications.
3.2 Document control, procedures, manuals, records and training. Consultancy on infrastructure and equipments following specific needs.
3.3 Preparation of a GLP Manual as a final product, including all the procedures, techniques and support documentation for the proper compliance of GLP.
- Development of Formulations
Each product or application requires a specific formulation that will allow to obtain the maximum advantage of the components’ features, being safe for the consumer. When the laboratory develops formulations that involve different presentations, therapeutic combinations or new ways of dosage, it increases their differentiation and commercial range of possibilities.
4.1 Consultancy in the development of formulation following client requirements
Preparation or improvement of declarations by pharmaceutical presentation.
4.2 Staggered batches and production.
Development of preparation methods, in accordance with equipment availability and current preparation conditions.
- Implementation and Design of Facilites and Laboratories
 The proper performance of a laboratory starts by a proper design and distribution, that will facilitate operations and control of the activities within it.
When you design and implement properly your premises, the laboratories ensure that the activities done comply with the necessary requirements to guarantee the quality of the products to be produce or analyze.
5.1 Consultancy on infrastructure and equipment of processing facilities and analysis laboratories.
Evaluation of technical and operational requisites, according with the type of analysis, products, regulations that apply, quantity and volume of units to work.
5.2 Establishing needs in accordance with the desired working features.
Establishing working areas and its requirements.
- Processes Validation
Processes validation is the act of demonstrating in a documented manner that an activity or an operation, acceptably compiles in giving the expected results.
When organizations validate their processes or operations they ensure the quality of their products against possible variables that may affect them, establishing by this mean the repetitiveness of their quality standards.
6.1 Specific Validation Programs and Plans for processes.
Determination of capacity and processes suitability that apply. Improvement and documentation to demonstrate their utility, repeatability and security.
6.2 Prospective, retrospective and coinciding validations and revalidation, in accordance with the needs and nature of processes.
6.3 Compliance with international regulations that are applicable to the developed processes.
- Development of Stability Tests
The stability tests allow to know if the products, in its different presentations and formulations, preserve the quality features that were given when prepared.
When developing stability tests the laboratories can verify the behavior of their products in time, ensuring an appropriate presentation to the customer. If any defect exists they can be investigated and opportunely corrected.
7.1 Programs and Plans of natural and accelerated stability.
Evaluation of products stability in their different presentations and formulas, so they are safe and effective for the customers.
7.2 Implementation of facilities and control systems related with the conditions in which the stability tests are developed.
Following current international regulations (ICH / USP / FDA) for stability tests, in accordance with the nature of the products and their conditions for use.
7.3 Preparation of Protocols and Reports of Stability per product.
Proper documentation regarding methods, techniques and study results, that reflects clearly the status of the evaluated product and that allow valid conclusions.
- Training Courses
Training allows to improve personnel competitiveness within an organization. It gives them new knowledge, reinforcing or updating different trends related with typical job activities..
An organization with suitable training policies will ensure a better performance and higher productivity of its operations. This will allow them to compete with an advantage on the market of product and services.
8.1 Training Programs and Plans on specific technical topics.
In accordance with the organization requirements, type of products or services, strengths and weaknesses, training programs are developed to strengthen personnel ability in the organization.
8.2 Permanent regulatory and technical assistance in accordance with the clients’ processes and services type and nature.
Timely update regarding new regulations and trends related with activities developed by the company, so it can adequate them promptly and transform them on tools for improvement and support.
- Consultancy in Sterilizing Processes
Sterilization is a process by which the contamination of a product by microorganisms is eliminated from the product and its components. It can be applied during the process or at the end, in each case it is necessary to evaluate the most suitable method to ensure the expected results without damaging the product’s feature.
This consultancy allows the client to ensure the best suitable method for their products and also to develop this method in an effective manner.
9.1 Sterilization by Humid or Dry Heat, Radiation, Ethylene Oxide.
Determination of the best possible conditions, in accordance with the product nature and process to use. To ensure optimal and secure results that allow clients to continue entrusting their processes and prevent possible damage to customers.
9.2 Development of techniques and processes validation in accordance with international regulation and standards.
Each type of process requires special conditions that are regulated by national or international standards, to ensure a safe manufacture, in which efficacy and repeatability can be demonstrated.
9.3 Consultancy on equipment and implementation of sterilizing systems, in accordance with specific needs.
Depending upon the product nature and the care used to handle it, the requirements of facilities, infrastructure, materials and other process components, are established.
- ISO 17025 Laboratory Quality Management
 ISO 17025 Standard stated the guidelines that a laboratory must follow to guarantee the quality and reliability of the offered services.
Having the certification allow analysis laboratories to offer quality services and ensure a working system that guarantees the trust of the methods and techniques used with reliable results.
10.1 Implementation of a quality system in accordance with ISO 17025 requirements.
Determination of requirements to comply with ISO 17025 Standard following what it states, considering the type of services that the laboratory offers and the products handled.
10.2 Consultancy to Certificate ISO 17025 Laboratory Quality Management System.
Preparation of a working plan, with monitoring and permanent support; giving the organization the necessary tools to an appropriate and opportune implementation of the system.
10.3 Audits and Trainings proper of the system maintenance.
Development of audits to evaluate the system status of implementation or the degree of compliance. The results with be used as a tool to correct or improve the organization. Also, the service considers the adequate personnel training in topics related with the standard and its scope, to ensure the proper performance of personnel within the organization.
- Supplier Evaluation and Control
Suppliers are a core part on the development of a product or service because the features of the products or services that they offer will affect in the products or services that we offer to our clients. Therefore it is vital to establish a proper mechanism that allow us to verify if their quality standards agrees with what we expect as final product.
Having a service of Supplier Evaluation and Control will allow the organization to have an effective tool to control and opportunely eliminate possible defects before these can affect in your operations or services, also better supporting relationships can be established opportunely with suppliers when exchanging quality prospects.
11.1 Evaluation and consultancy to critical suppliers.
Determination of strengths and weaknesses in critical suppliers of the supply chain to prevent quality problems in products or services because of non attended deficiencies.
11.2 Determination of requisites for qualified suppliers.
Establishment of requirements that must by complied by suppliers according with the organization nature and needs of their products and services. Suppliers will become effective allies in producing quality products and services that will satisfy the final client.
11.3 Preparation and implementation of a supplier evaluation and control program.
Establishment of a supplier evaluation and control program, whose inspection visits and monitoring reports will be used to ensure the maintenance of conditions originally established or to be aware if the changes done on the suppliers processes can potentially affect the organization’s products and/or services.
11.4 Training Suppliers
As an option, the organization may use the data collected during the evaluation and control to offer training for their suppliers. A training specially targeted to help them comply with the non-compliances found, in accordance with the organization needs and requisites.
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