Validation of Manufacturing Processes and Analysis Methods
- Process analysis
- Protocol preparation
- Execution of the validation, tracing of manufacturing batches
- Statistical analysis of the process variables
- Preparation of validation reports
- Implementation of identified improvements
- Continuous verification of the validation status
Physical-chemical and Microbiological Quality Control
We count with a broad quality control and microbiology control laboratory for the performance of tests related to:
- Sampling and analysis of raw materials and products
- Analysis of packing and packaging materials
- Sampling and analysis of environments
BPL-Certified analysis methods and analytical techniques:
- Technique Description, Dimensions, functional testing for packing and packaging materials, gravimetry (Loss due to drying and weight, Residue on Ignition, filling weight, sulfated ashes, others), Solubility, Conductivity, pH, refraction index, polarimetry, Density / specific gravity, siege particle size, viscosity, hardness, friability, tightness, disintegration.
- Threshold testing
- Chemical-reaction testing
- High-Performance Liquid Chromatography– HPLC
- Gas Chromatography GC
- Thin Layer Chromatography TLC
- Karl Fischer water content determination
- Mesophilic, fungi and yeast recount testing
- Preservative-efficacy testing
- Identification of specific microorganisms
- Analytical method validation
We guarantee reliability with respect to the results issued, and we adhere to the specific requirements of each one of our clients, ensuring maximum quality in our processes.
- Materias primas.
- Material de envase y empaque.
Storage and distribution
- Purchase of Raw Materials and Packaging Materials:
Experienced in negotiating Raw Materials and Packaging Materials for the pharmaceutical industry
- Product storage:
- Experienced in handling products of the Pharmaceutical Industry and products of the Chemical Industry.
- We handle various levels of hazardousness classified in accordance with the Globally Harmonized System (GHS) of the United Nations.
- Management of Exports:
Management of EXW, FCA and FOB Export processes
To achieve the best results possible, in Altea Farmacéutica S.A. we innovate every day using the best technologies of the pharmaceutical industry.
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