U Med Laboratories provides Good Manufacturing Practices (GMP and cGMP) validation services to pharma, biotech and associated industries regulated standard such as ISO-14644, EU-GMP,WHO,USFDA.

We are a full-service company, providing expertise and assistance through every phase of your validation projects. You will ensure a faster, more efficient and cost-effective implementation with our proven processes.

VALIDATION CONCEPT:

  V – Model Concept:

The approach for qualification / validation is adopted from the V-Model concept. This approach is based on the philosophy that validation begins at the conceptual stage of a project and continues throughout the life cycle of the system. The process begins by need identification in the form of URS, followed by functional specification and Design specification and their relevance with various stages of validation as illustrated below:

  Qualification / Validation contains the following phases

1.       User Requirement Specification (URS),

2.       Function Specification (FS) / Function Design Specification (FDS)  ,

3.       Design Specification (DS) / Design Qualification (DQ),

4.       Installation Qualification (IQ),

5.       Operational Qualification (OQ) &

6.       Performance Qualification (PQ).

 User Requirement Specification (URS)): is a document that describes the intended use along with requirements & acceptance criteria considering basic functional and design aspects from which detailed functional & design specifications can be drawn.

URS is linked to Performance Qualification, which tests the system in its operating environment with the product.

Commissioning is the process of ensuring that all business critical and GMP building utilities, equipment and process equipment are designed, installed, functionally tested, and capable of operation in conformance with design intent.  Commissioning activities will be directed by Technical Background Document with a level of oversight applied by the site Quality Assurance and Facilities Engineering.

Functional Specification (FS) / Functional Design Specification (FDS) is a document that describes the detailed functional attributes along with necessary safety features wherever applicable.

FS is linked to Operational Qualification, which tests all functions specified as per the requirements / defined in the FS without product.

Design Specification (DS) / Design Qualification (DQ) is a document that describes the design aspects in sufficient detail to enable it to be constructed, installed and qualified.

DS is linked to Installation Qualification, which checks that the correctness of supply and the installation.

Installation Qualification (IQ) verifies and documents evidence that all key aspects of installation meet the approved design specifications as intended and that the installation recommendations derived from in-house / manufacturer / supplier, have been suitably achieved.

Operational Qualification (OQ) verifies and documents that the installed equipment / system operates within typical or anticipated operating ranges indicated in the Functional specification without actual product.

Performance Qualification (PQ) verifies and documents evidence that the system in its normal operating conditions performs as intended with placebo (OSD) throughout anticipated operating ranges.

Process Validation (PV) verifies and documents evidence that the process in its normal operating conditions performs as intended and produces product complying to pre-determined specification and quality parameters consistently.

  Complete Validation will be provided for all oral Equipments as per validation concepts:

1) Coating machine,

2) Compression machine,

3) Fluid bed Dryer &FBC

4) RMG, Blender,

5) Sifter and Multimill etc.

3) Complete Validation will be provided for all Injection Equipments as per validation concepts: –

1) Tunnel,

2) DHS,

3) Autoclave,

4) Filling machines,

5) Lyophilizer,

6) Washing machine,

7) Isolators,

8) Lyophilizer 

Complete Validation will be provided for all Primaries &secondary packing equipments as per validation concepts: –

1) Blister packing machine

2) Strip packing machine

Utilities Qualification

The following GMP utilities supply services needed for operation of the facility and equipment. These utilities have either direct contact with the product or forms as components for the product.

1.       HVAC system

2.       Purified water system

3.       Water for Injection System

4.       Compressed air system and other gases

5.       Pure Steam generation and distribution system

Other Utilities which are listed below shall be commissioned as per GEP as they do not have direct impact on the product quality. 

a)      Chilled water generation and distribution system

b)      Hot water generation and distribution system

c)       Potable water distribution

d)      Electrical distribution system

e)      Raw Steam Generation & Distribution System

f)       Drainage system

Trainings for mentined topics

U Med Laboratories has a dedicated training department which specialises in client in-house training alongside general training courses. Our in-house training courses are tailor-made for each individual client. Our courses span all areas of validation activities and U Med Laboratories routinely conducts training on all services that we offer.

As part of each training course package, U Med Laboratories conduct an assessment on all participants at the end of each course, to assure full comprehension of all issued covered.

In addition to our in-house training seminars, U Med Laboratories holds an annual industry forum. These forums aim to address topical issues within the industry and relevant audit implications.. These forums are aimed at key personnel from all areas including, technical services, validation, project management, production, logistics, laboratories and QA/QC.

Training on all services that we offer.

1)                  Media fill summation study

2)                  SIP/CIP

Risk Assessment

An in-depth risk assessment of any project can be conducted by our highly trained engineers at Autocal Ireland. We evaluate the risk for each function of a system in the event of worst case scenarios. This process classifies the criticality of each risk and we suggest the protective measures to ensure that courses of action are put in place to minimise the effect of the risk. Our study is a means to identify potential hazards to a process or product, both prospectively and in a reactive mode. Risk assessment is an effective tool in supporting the decisions of which functions/sub functions in a large system require formal validation testing. A thorough process mapping exercise followed by thorough risk management follows.

As part of a risk assessment plan all possible risks, GXP and business risks, must be established. It must also be established under what situations that theses risks may occur and what level of impact they exert.

Six Sigma Approach to Continuous Improvement

Once a risk management plan has been developed and implemented, focus can now be shifted onto approving the processes that are already in place. As part of the continuous improvement to all process Autocal can implement a strategy to implement the six sigma approach when assessing possible improvements within a venture. Using six sigma we are constantly trying to achieve quality that strives for near perfection, as six sigma is a disciplined data driven approach and methodology for eliminating defects in any product, from manufacturing to transaction and from product to service.

The fundamentals of any six sigma project are the implementation of a measurement based strategy that focuses on process improvement and variation reduction through application of either of the two six sigma sub-methodologies DMAIC and DMADV.

Document Preparation

Whether purchasing a new process or equipment or updating existing documents the requirement to produce compliant and accurate documentation is essential. U Med Laboratories provides an excellent service in drafting of documentation for all areas within the pharma industry. We have assisted many clients over the years in drafting of design specifications and user requirement specifications for processes. Once the process has been procured we have written and performed factory acceptance tests in conjunction with the IQ, OQ and PQ documents for the equipment. Once the equipment had been installed and validated, U Med Laboratories can prepare all revalidation documentation, Batch manufacturing records & standard operating procedures.

U Med Laboratories can provide a stand-alone service where we project manage the drafting of all documentation for a particular process of for the entire plant. Alternatively U Med Laboratories can place an engineer into the existing project team where they can assist in the drafting of the documents.

Preparation of SOP's

The primary purpose of an SOP is to identify hazards associated with a specific operation and to document the means by which those hazards are mitigated.

Once a validated state has been achieved for a particular piece of equipment/system, U Med Laboratories have the expertise and experience to draft thorough and accurate operational procedures to ensure that the equipment is ran within its validated parameters and that the machine is maintained and remains operating correctly.

Examples:

Standard operating procedures for:

1.      Revalidation procedures for all equipment/systems

2.      Operating procedures for equipment/systems

3.      Positioning of loads during autoclave processing

4.      Procedures for writing documentation/Batch records

5.      In house training procedures

6.      Microbiology Laboratory sops

7.      Production SOP

8.      QMS System SOP

9.      Aseptic processing SOP

10.  VMP

11.  Cleaning Validation Master plan

Audit Preparation

Autocal actively assists many companies in audit preparation. We offer an exceptional reviewing service in all areas of GMP, GDP and GLP. We analyse documentation, procedures and methodology pertaining to practices and from this, should problem areas exist, Autocal will draft a revision plan which would highlight recommended changes and amendments that should be implemented

Autocal offer an audit preparation and review service of the following:

·         GXP's

·         All documentation review encompassing protocols, SOP's BMR's etc.

·         VMP

·         Cleaning Qualification

·         Process Qualification

·         Cold chain Qualification

·         Warehouse Qualification

·         Thermal Qualification

·         Training Procedures

·         Computer System Qualification

·         Utilities Qualification

Monitoring Of Indoor Air Quality As Per ASHRAE / EPA Standards

1.      Temperature

2.      Relative Humidity

3.      Air Movement

4.      Ventilation (CO2)

5.      Particle Concentration in Cleaned HVAC System

6.      Air borne particles

7.      Ultra Fine Particles

8.      Carbon Monoxide

9.      Air borne contaminnants such as CO,NOx, Volatile Organic Compounds (VOCS)

10.  Particles particularly less than 4 micron (Respirable)

11.  Biologicals Bacteria, such as fungi, mold and pollen.

12.  Indoor Air Quality - Ultrafine particle tracking

PLC Validation

U Med Laboratories covers various equipments/machines with their own PLC based Automation System as well as will be procuring similar automated equipment for their future requirements.

The equipments the Building designs incorporate Good Manufacturing Practices and are based on International Regulatory requirements and current technological advancements.

U Med Laboratories strongly believes that Validation is a necessary part of a quality assurance program. It is a fundamental to build system in the quality of the products and achieving consistency and efficiency in manufacturing operations.

Master Validation Plan covers the equipment having Programmable Logic Controller based systems.  It defines the extent of the validation program and lays down broad guideline for the various validation activities to be carried out in line with the validation .

PLC PROTOCOL WILL COVER AS FALLOWS:

                                               

1.0          INTRODUCTION                                                                                   

2.1          Scope   

2.1.1       Objective

2.1.2       System Description

2.1.3       Scope & Applicability

2.1.4       Level of Detail

2.1.5       Electrical

2.0          ORGANISATIONAL STRUCTURE                                                         

3.1          Responsibilities

4.0        VALIDATION STRATEGY AND DELIVERABLES                                   

4.1           General

4.1.1       List of the PLCs

4.1.2       Documentation

4.1.3       Instrument Inspection and Calibrations

5.0        QUALIFICATION PROTOCOLS                                                

5.1          Control System Installation Qualification (CIQ)

5.1.1       Equipment Details

5.1.2       Verification of Master Documents

5.1.3       Verification of Engineering Drawings (“ As Built”)

5.1.4       Verification of PLC system Hardware Components

5.1.5       Verification of Communication Cables

5.1.6       Verification of PLC Panel Arrangement

5.1.7       Verification of Power Utility

5.1.8       Verification of Software Backup

5.1.9       Verification of Software Configuration and Source Code

5.1.10     General System Inspection for PLC Panel

5.1.11     Programmable Function Keys (PFKs) and Displays Verification

5.2          Control System Operation Qualification (COQ)

5.2.1       Testing of PLC Processor

5.2.2       Testing of PLC Inputs / Outputs

5.2.3       Testing of System Security

5.2.4       Testing of Programmable Function Keys (PFKS) and Displays

5.2.5       Verification of Environmental Conditions

5.2.6       Testing of Power Failure Conditions

5.2.7       Testing of Communication Failure Conditions

5.2.8       Testing of Alarm / Messages

5.2.9.      Operational Testing

5.2.10.    Review of Relevant Sops for the PLC System

5.2.11.    Verification of System behavior as per the USFDA 21 CFR Part 11 Clauses

5.3          Discrepancy Report

5.4          Validation Report

6.0          VALIDATION EXECUTION AND DELIVARABLE                        

7.0          ACCEPTANCE CRITERIA                                                                        

8.0          CHANGE CONTROL                                                                             

9.0          TRAINING REQUIREMENT                                                                   

9.1          Selection and Training

9.2           Education / Training

10.0        DOCUMENTATION REQUIREMENT                                                         

11.0        MAINTAINING THE VALIDATED STATE                                                 

12.0        TERMINOLOGY                                                                                     

           

REFERENCES  

Thermal Qualification

U Med Laboratories has been providing a world class service in thermal validation to the Pharma industry. In order to ensure the highest level of safety and efficacy in manufactured products, all processes used throughout the manufacturing, packaging and storage facilities, are required to be validated.U Med Laboratories specialises in the qualification of the following equipment:

1.      Cold rooms

2.      Fridges

3.      Freezers

4.      Warehouses

5.      Stability Cabinets

6.      Incubators

7.      Depyrogenation Ovens

8.      Depyrogenation Tunnels

9.      Lyophilizers

10.  Autoclaves           

11.  Dry Heat Ovens

12.  Furnaces

13.  Ultra Low Freezers

14.  SIP Systems

15.  CIP Systems

All U Med Laboratories engineers come equipped with a suite of validation test equipment which is fully part 11, Annex 1 and GAMP 4 compliant. Our engineers have also received extensive training in various other test equipment and would be entirely competent in utilising client’s in-house equipment.