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Qualification & Validation

Validation Support by BCI enables pharmaceutical and medical devices manufacturers to overcome critical implementation challenges through a collaborative partnership with BCI - the world-wide leader in pharmaceutical and medical devices validation
BCI has delivered numerous projects including capex projects, FDA/MHRA remediation projects and written several technical documents. Our technical team consisting of skilled professionals can offer practical knowledge to enhance the quality systems to meet the regulatory requirements. Whether it is an existing facility, or a brand-new facility manufacturing pharmaceuticals, medical devices or biologics; our consultants can navigate their way through the regulations and help you set up a compliant and practical validation strategy.
Whether your challenge is rapid delivery of novel life-saving therapies or aggressive cost and schedule pressures when delivering new manufacturing capacity, we drive project success. When the inevitable challenges arise, we establish risk mitigation and contingency plans to overcome the obstacles. We drive success by staying focused on project scope and requirements.
BCI executes validation projects on a quote basis or offers our experienced Validation Consultants or Engineers at a daily or hourly rate based at your site. After many years of consulting and working in validation our experts have gathered a formidable library of key project documents, ranging from Site Validation Master Plans, User Requirements Specifications (URS), Functional Specifications (FS) and Detailed Design Specifications, so we can comfortably and efficiently gather and document your key requirements. Our documents are designed and laid out to promote the efficient generation of qualification protocols such as IQ, OQ and PQ. However, it’s not just the documents but the hands on practical experience, expertise, skills, professional knowledge which is invaluable and help clients to meet their own requirements as well as the regulatory requirements.
We have successfully supported Pharmaceutical, Healthcare and Medical device companies to achieve regulatory compliance (MHRA / FDA) with flexible working patterns and excellent cost efficiency.

Technical Documentation (URS, FDS, VMP, DQ, IQ, OQ, PQ, PV and CPV)

BCI provides a whole package of validation services and has core experience in understanding the validation requirements of the Pharmaceutical, Healthcare and Medical Device industry. Our validation consultants are well versed with the requirements of cGMP and regulatory authorities. Our specialists work closely with the client to ensure that the design and documentation of any new process / equipment/ facility/ utility is thoroughly prepared and fully validated, and any changes occurred thereafter are re-validated to meet the stringent requirements of the regulated agencies. BCI assists you in compiling validation and qualification plans, protocols and their executed reports like SVMP, VMP, FMEA, URS, FDS, FAT and SAT, DQ, IQ, OQ, PQ, PV, CPV, maintenance, calibration, cleaning SOP’s/WI, NCR’s, CAPA, change controls, all sorts of monitoring and sampling techniques, and qualification and validation of cleaning and sanitising cycles, clean rooms etc.

Qualification and Validation Management

BCI offers wide range of validation services to our customers by offering risk-based solutions to their validation and regulatory compliance requirements. Our consultants and practitioners can live up to the client’s expectations by smart use of their skills, experience and knowledge of the regulatory requirements of various countries and support our customers in all phases of risk-based validation. We use a risk-based approach to determine which process to validate and offer assistance in qualifying the critical equipment and validating the critical processes. We help in organising, planning and compiling the qualification and validation stages of equipment, facilities, utilities and systems by setting up validation master plans, performing gap analysis and compiling the respective technical documentation as per the requirements of cGMP, regulatory authorities and site policy. We have successfully supported pharmaceutical, healthcare, Biotech & Medical Devices companies to achieve regulatory compliance (MHRA, FDA, ANVISA, IMB, TGA etc.) with flexible working patterns and excellent cost efficiency.

Equipment Qualification & Validation (DQ, IQ,OQ,PQ)

We have experience in validating a wide range of Pharmaceutical and Medical devices equipment such as:

  • Processing Equipment’s: Autoclaves, Blenders, Filtration Units, Fluid Bed Dryers, Granulators, Glassware / Vial Washer, Pumps, Mixing Vessels, Storage Vessels, Tablet Press etc.
  • Filling and Dosing Systems: Liquid Filling, Solid, Creams, Ointment or Powder Dose, Coating and Imprinting, Drying and Spraying.
  • Coders and Vision Systems: Vision Systems, Coders, Laser Printing, Inkjet Printing and Data integrity, Labelling and Inspection for Barcodes.
  • Packaging equipment: Blister Packers, Cappers, Trayers, Checkweighers, Cartoners, Labellers, Case Packers, Multipack collator, Control systems, Palletisers.

Process Validation (PV) and Continued Process Verification (CPV)

As we all know the saying; we cannot test quality into products, but we have to build it in at each step of the process. At BCI, we use risk-based approach to determine which process to validate and offer assistance in qualifying and validating the critical processes. We evaluate the critical quality attributes (CQA) and critical process parameters (CPP), sampling strategies, monitoring techniques which will help in the development and execution of the process validation studies. Continued Process Verification (CPV) the final stage of validation is to control the validated state of the process. To achieve this, we help you to devise monitoring plans to collect, monitor and evaluate data and then represent this data on statistical control charts which helps to determine the process stability and capability and in turn helps to produce the desired product which meets its specifications, whilst adhering to cGMP and regulatory requirements.

Product Validation

At BCI, with our core experience and knowledge we help you to identify the critical products to validate and accordingly set up plans and compile protocols to validate the products. Some of the products are:

  • API: Drugs ,Tablets, Syrups
  • Liquid products: Syrups, Lotions, Suspensions, oils
  • Dry products: Powders, Tablets, Capsules
  • Gel products: Creams, Ointments

Clean utilities (Purified and Water for Injection system) qualification and validation

Water the vital ingredient in all Pharmaceutical, Health care and Medical Device industries must be clean and free from microbial contamination and must fulfil all regulatory requirements. Purified water (PW) and Water for Injection (WFI) are widely used and must have specifications as per the United States Pharmacopeia (USP) and European Pharmacopeia (EP) requirements. Other clean utilities include compressed air, clean gasses (like nitrogen and oxygen), clean steam, etc. At BCI; our expert consultants help you to design suitable water systems as per the pharmacopeia requirements. This involves selecting the pre-treatment and generation method based on the source of water at site and then the distribution of this water based on your requirements either as an ingredient in finished pharmaceutical products or in the cleaning of equipment’s.
We help you to design these pharmaceutical grade distribution systems considering various critical factors to avoid contamination, cross-contamination, and microbiological growth. These factors are requirements regarding welding, passivation, pipe slope, velocity/ turbulent flow, sanitary food grade components, materials and their correct specifications, cleaning cycles, etc.

Control Systems Qualification and Validation

BCI offers complete automation solutions tailored to your requirements for all process stages, right from verifying the product quality through measuring, monitoring, labeling, counting, packing, coding, marking and testing of the processes. We help in generating the requirements and design specifications for all types of automated control systems.

Monitoring, Qualification and Validation of Clean Rooms, HVAC systems

Clean rooms in the pharmaceutical, medical device or healthcare industries are specially designed, constructed, environmentally controlled enclosed spaces where the concentration of airborne particles (contaminants) are required to be kept within specified limits, along with the control of other environmental parameters such as air flow, temperature, humidity and pressure. At BCI, our clean room experts help you to design, install, commission and validate your clean room and HVAC systems as per the regulatory requirements that are relevant to your needs. While designing various factors are considered:

  • Clean room architecture – Material of construction and surface finish of clean rooms walls, ceilings and floors.
  • Integrity of the clean room environment with the HVAC system – cleanliness guidelines, airflow streams, room pressurization, temperature, humidity and filtration (HEPA) requirements.
  • Monitoring systems.
  • Movement of people and maintenance /cleaning schedules.

Vision System Qualification & Validation

We at BCI help you provide complete and thorough validation for all your vision systems on production and packaging lines by providing solutions for ISO verification, serialization, artificial vision, proof reading technology, implementing traceability for product safety, and to minimize quality control problems and product recalls whilst adhering to the current regulatory standards of GAMP-5 and validation requirements of 21 CFR part 11.

Cleaning Qualification & Validation

Our experienced consultants at BCI use risk based approach and assist our clients by providing validation / verification and Process development of cleaning procedures in compliance with regulatory guidelines. Our cleaning validation service handled by our consultants help you with the cleaning procedures (SOPs) such as:

  • Responsibilities and cleaning schedules
  • Methods to ensure proper cleaning and maintenance
  • Automated, Semi-automated and Manual Cleaning Procedures
  • Equipment design reviews
  • Calculation and setting up of residual acceptance limits and their acceptance criteria
  • Sampling Procedures
  • Inspection of equipment for cleanliness before reusing
  • Documenting cleaning validation results
  • Generating validation protocols and reports

Computer System Qualification & Validation

Our Computer System Validation consultants can assess your computer systems compliance against regulatory standards and expand computer system validation. We ensure that systems operate according to the functional requirements and regulatory specifications and guidelines as well as Good Automated Manufacturing Practices (GAMP). We use a risk-based approach for computer system validation and also help in assessing the failure of automated systems. Our CSV experts help to document the test cases and provide complete, approved and secured test scripts.

Analytical Method Validation

Analytic method development, validation, and transfer are key elements of any pharmaceutical development Our specialised method analysts at BCI, help in drafting analytical procedures through method development design, method validation protocol, interim reports, and remedial validation to meet your needs and comply with the current ICH guidelines by ensuring you meet all regulatory demands. If required, we also validate your existing methods based on customer-specific validation plans which enable us to meet your exact requirements.

Requalification / Revalidation

We at BCI help you carry out revalidation/requalification of all your processes, product, cleaning revalidation, analytical method revalidation due to changes in processes when deviations occur, change in the design of the product, requirements of current regulations/ standards and on periodic basis. Our experienced validation specialists will guide you to review and evaluate the existing processes, product and compile the protocols based on the historical data available from monitoring of key quality attributes, process control data, and final product testing.