PHARMACEUTICAL SERVICES

Research and Development

QUIBI Quibi’s fully-equipped and GLP certified laboratory allows for rapid development of scalable and robust chemical processes using advanced methodologies to provide effective I+D procedures and a quick response in every phase of development of medicines.

We work under the direction of qualified professionals to design pharmaceutical forms that guarantee the effectiveness of each product.

Investigación y Desarrollo

The research and development area offers:

Formulation design and development.
Preparation of pilot batches.
Preparation of natural and accelerated stability studies in zone IV (INVIMA, ICH).
Stability studies “ON GOING”.
Preparation of dossiers for the application of sanitary registrations.
Storage of products in stability rooms with adequate temperature and humidity.

Analytical and Validations Control

QUIBI has a complete research, development, and validation center equipped with scientific and technological tools to carry out effective validation processes.

We work under the direction of qualified professionals to design pharmaceutical forms that guarantee the effectiveness of each product.

Validaciones Farmacéuticas

QUIBI can provide services such as:

Development and validation of analytical methods or techniques.
Production process validation.
Cleaning process validation.

Quibi's Point

QUIBI PUNTO

Flexible and economical alternative!

Post-consumer Return Management Plan for Expired Medications

QUIBI PUNTO is an alternative for the management of post-consumption return of expired medications.QUIBI PUNTO is available to manufacturers, distributors, or pharmaceutical retailers.

QUIBI, aims to promote and safely manage the gathering of expired medications of human and veterinary use, which are in the hands of doctors, patients, drugstores, and the general public, and thus giving this medications an environmentally responsible and appropriate disposal.

Quibipunto

We comply with resolution 0371 of 2009.
Presentation of the COLLECTIVE MANAGEMENT PLAN FOR THE RETURN OF EXPIRED MEDICATIONS.
Implementation of a mechanism for the return of expired drugs that includes the entire commercial chain.
Population coverage; meeting the goals and annual increases required by the Ministry of the Environment and Sustainable Development.
Location of containers at strategic points.

Quality Control

Quibi is part of the select group of companies certified in Good Laboratory Practices (BPL). In Colombia only 7 of 120 laboratories have this certification.

Our quality process is based on the demanding selection of raw materials, packaging materials, technological resources, production techniques and an excellent human team, exclusively dedicated to the quality control of all processes, from the beginning of production to the final packaging and packing.

Control de Calidad Farmacéutica

Physical and chemical analysis.

Identification, physicochemical parameters and HPLC titration.
Identification, physicochemical parameters and titration by spectrophotometry.
Identification and titration for cations by atomic absorption.
Determination of total organic carbon (TOC).
General analysis of raw materials and active ingredients according to pharmacopoeia specifications.

Microbiological Analysis.

Limuslus Amebocyte Lysate (LAL) pyrogen test.
Sterility test.
Counts of mesophilic aerobic microorganisms.
Tension tests and total coliform counts.

Medical Devices

QUIBI is certified by INVIMA for the manufacture, packaging, and storage (CCAA) of medical devices for protection and prevention; devices for perfusion, administration, extraction, or introduction into the body; products for disinfection and sterilization with their parts, as well as accessories and supplies in ambient temperature conditions.

Dispositivos Médicos

QUIBI has the INVIMA certificate of sanitary conditions for the following processes with medical devices:

Semifinished
Packaging
Sterilize
Store
Condition
Market

Microbiological Analysis.

Limuslus Amebocyte Lysate (LAL) pyrogen test.
Sterility test.
Counts of mesophilic aerobic microorganisms.
Tension tests and total coliform counts.

Equipment for perfusion, administration, extraction, or introduction into the body (administration and drainage system for continuous ambulatory peritoneal dialysis C.A.P.D., continuous automatic dialysis, A.P.D. and hemodialysis), pre-filled syringe, hemoperfusion systems, hemodialysis, colon irrigation, for enemas, enteral and parental nutrition in room temperature conditions.

We are also certified for the manufacture, packaging, packing and storage of medical devices such as contact lens and anti-fogging solutions.

Storage and Distribution

Storage and conditioning of finished products for distribution and commercialization at national and international level. We have presence in Mexico, El Salvador, Curaçao, Suriname, Venezuela, Ecuador, Peru, and Dubai among others.

Distribución y Almacenamiento

Warehousing Services Packaging and Coding

We are aware of the importance of maintaining the quality of medicines from packaging to storage and subsequent distribution so that they reach users in optimal conditions, maintaining the stability of medicines through adequate conditions of light, temperature, humidity and good manufacturing and storage practices for raw materials, packaging materials, containers and finished products.

Certifications

QUIBI has obtained the following certifications as a result of complying with the strictest quality standards in manufacturing and services rendered within the pharmaceutical industry, both nationally and internationally:

Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
DIGEMID
Cofrepris
ICA Good Manufacturing Practices ("BMP-ICA")

Certificaciones Quibi

We are committed to excellence and quality in the provision of services and the continuous improvement of all our processes to ensure that the manufacture of products complies with the strictest standards of uniformity and control.