In a pharmaceutical production plant API or with applicable regulations as cGxP’s is mandatory to have the systems and processes validated and that they comply with proper lifecycle in accordance with applicable regulatory and internal requirements. Therefore we offer not only solutions aimed to systems validations, but also to ensure proper monitoring of the life cycle thereof, thus encompassing the stages of initial design, project (planning, specification, verification, reporting), operation, and the final stage of withdrawal from the system, always keeping in mind the premise of compliance with the regulatory framework cGxP, and ICH Q8, Q9 and Q10 (space design, risk management for quality and assurance activities commensurate) and specific requirements in each case.
The purpose of the cleaning validations is to demonstrate the effectiveness of the cleaning procedures used or to be used. Thus, it is evidenced in a document way that the cleaning procedure for the areas and equipment used in the manufacture of products, reduces to a pre-established level, both the residues of the cleaning agent and the processed product.
Vality Pharma Consulting performs the study of risk analysis and the identification of the worst case in production lines for different products and processes, or for the implementation of new cleaning processes.
In many occasions the cleaning processes are complementary to those of sterilization, as in the case of Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems, or by other physical or chemical sterilization processes.
Vality Pharma Consulting develops validation projects of computerized systems in order to provide documented evidence that an electronic system or technology will work as specified. This evidence must be clear, repeatable and supported by audits. There are a series of steps to include in any validation initiative.
A risk assessment identifies the potential risks to consider when we embark on a new project.
The scope and planning of requirements are also identified so that users and the implementation team know what the project will include, and how to plan and support it.
A detailed validation plan establishes the activities that will be carried out to provide evidence that the new system is properly validated, the conditions that must be met to make it work, and the procedures that will be maintained to preserve the validated status after release.
The documentation written by Vality Pharma Consulting will be pre-approved, executed and post-approved during the course of the IQ, OQ and PQ validation project according to Good Automated Manufacturing Practice (GAMP V), CFR 21 part 11, Data Integrity and Compliance with CGMP Guidance for Industry (ALCOA).
The FDA defines the validation of a process as the establishment of documented evidence that provides us with a high degree of assurance that the specific process will consistently generate a product that meets predetermined specifications and quality characteristics.
The perfect knowledge of the development processes of the products and the equipment involved, implies an improvement in the productivity and quality of the products. This is why, Vality Pharma Consulting has qualified technicians to develop validation projects, as indicated in the guidance note (CPMP / QWP / 848/96, EMEA / CVMP / 598/99).
The guide complies with the ICH Q8, Q9 and Q10 documents and the possibility of using continuous process verification in addition to, or instead of, processes in a traditional manner, together with risk management tools under a quality system described by ICH Q8, Q9 and Q10.
Vality Pharma Consulting can validate:
• Manufacturing processes
• Laboratory equipment
• Process equipment
• Analytical instruments
It is recommended to carry out a risk assessment of the expansion and manufacturing processes. Vality Pharma Consulting has a group of experts from multiple disciplines to ask the following questions:
- What could go wrong in the process?
- How often could that happened?
- What would be the consequences if the process fails?
The information obtained from the risk analysis will only be useful if the input is appropriate. The results of the risk assessment often dictate these essential requirements, as they ensure the production of a safe product that minimizes the risk to patients and consumers. Risk analysis in process validation promises to minimize the risk of the process. Risk assessment tools help define the process and identify areas and crucial steps in that process, areas of risk or danger, and critical control points and the number of operations steps necessary to reduce specific risks to acceptable levels
In order to minimize the risk of a serious medical hazard due to cross-contamination, dedicated and independent facilities should be available for the production of certain medicines, such as highly sensitive materials (eg, penicillins, biological preparations and live microorganisms).
The production of certain additional products, such as some antibiotics, certain hormones, cytotoxics, and some highly active drugs and non-medicinal products, should not be carried out in the same facilities.
Vality Pharma Consulting focuses on Annex 15 of the GMPs, the Guide-line of the EMA and NCF chapters 3 and 5 in the analysis and subsequent documentation of the following aspects:
Confine the manufacturing activities to a segregated and autonomous production area within a multi-product installation.
Use “closed systems” to minimize exposure points in the processing and transfer of material / product between equipment.
Use automated cleaning processes with validated efficiency. The EMA has expressed its aversion for manual cleaning, especially with high-risk compounds.
Verify cleanliness after each product campaign. This verification should be considered as a detection tool to support the effectiveness of the Quality Risk Management approach for the products considered to be the most risky.
Separate the washing, drying and storage areas of the equipment.
Verification for the cleaning of contact surfaces that are not product and air monitoring within the manufacturing zone, to demonstrate the effectiveness of the control measures of mechanical transfer and airborne contamination.
Supervise personnel to ensure effective training and compliance with relevant procedural controls.
The logistics sector is an emerging and rapidly growing sector. In various areas, storage and logistics are key to ensuring optimal storage, transport and transfer conditions for products, especially pharmaceutical ones.
Vality Pharma Consulting has highly qualified personnel and a state-of-the-art instrumentation that allows us to perform the necessary services to comply with good transport and storage practices. This way we can ensure that the transportation, facilities and equipment are adequate and guarantee that the products are conserved and distributed in an appropriate manner without affecting their properties.
To this end, environmental conditions are checked during transport (land, sea or air), in different packages and in the warehouses and facilities themselves.
In order to comply with the Good Logistics Practices, the following services are carried out:
Thermal mappings summer / winter, empty / load, determination of cold / hot points.
Calibration of transport trucks and temperature and humidity probes.
Analysis and location of control probes.
Risk analysis of warehouse processes and transport routes.
Validation of packaging for refrigerated transport.
The regulations to be taken into account in order to comply with good transport and storage practices are as follows:
GMP – Standards of correct manufacture of the European Union.
USP 38 chapter 1079 – Good storage and distribution practices.
Royal Decree 782/2013 on the distribution of medicines for human use.
Guideline 2013 / C of the European Union on good distribution practices.
WHO Technical report series No. 961 2011, temperature mapping on storage areas.
