Audit Services
The SMB Validation & Compliance Services Group will develop and perform internal audits of the manufacturers methods. This procedure is fully documented so as to be able to track repeat problems and provide documentary evidence for the customer to prove that audits are, in fact, being performed.
SMB Group Inc. develops and performs audits for bought out items so as to allow the Equipment Manufacturer to ensure that suppliers follow approved procedures and supply appropriate documentation.
Quality Plan
The SMB Validation & Compliance Services Group can develop Quality Plans that document and delineate in detail the methods, tools and resources employed by a given equipment manufacturer in order to ensure that their products will meet the PMDB manufacturers’ regulatory requirements.
Validation Master Plans
SMB Validation & Compliance Services Group Inc. is available to Validation Master Plan to describe the activities, roles and responsibilities, and identifies where the process fits within the typical project lifecycle.
Installation Qualification Protocol
The SMB Validation & Compliance Services Group can develop Installation Qualification Protocols for each critical utility or piece of equipment. The protocol provides for a systematic method of checking the static attributes of the equipment before the equipment is used. The IQ will start with a description of the system. This description will describe what the system is intended to do, and all major components of the system. The system will be reviewed post-installation to verify that the system is as specified in the user requirement, detail design specifications, engineering drawings, data sheets, and manuals. As part of the IQ all such documentation will be identified and referenced.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Operation Qualification Protocol
The SMB Validation & Compliance Services Group can develop Operation Qualification Protocols to describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs are manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Performance Qualification Protocol
The SMB Validation & Compliance Services Group can develop Performance Qualifications to validate a complete integrated process (e.g. a packaging line consisting of several pieces of equipment). Performance Qualification Protocols test the performance and critical parameter testing for each individual piece of equipment on an integrated process. All set-up information is documented and samples are collected at the end of the integrated process based on ANSI/ASQC Z1.4-1993 general inspection levels and acceptance quality levels established by the end user.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Summary Reports
The SMB Validation & Compliance Services Group can produce summary reports upon completion of a review of each major step of the validation process.
Computer System Validation
The SMB Validation & Compliance Services Group will develop each of the various aspects of Computer System Validation. This includes System Life Cycle Methodology. SMB Group is able to define, document and implement the process of documenting and testing all the various aspects of a computer based control system/process, from its inception through its design, build and installation, and all the way to its eventual decommissioning.
Validation Project Management
Integrating packaging equipment from diverse and often, geographically dispersed manufactures requires particular attention and a high degree of validation project management. SMB Validation & Compliance Services Group is aware of this requirement and experienced in the skills of good validation project management.
During a recent major validation project Our task was to qualify a high-speed tablet packaging line. The various individual machines that had been specified for this line were built by one (1) Italian, four (4) US and two (2) UK based companies. And then integrated by a third party in the UK for a large German equipment manufacturer who, in turn, had sold it to a pharmaceutical manufacturing company in Singapore.
This project certainly needed a degree of planning (and flexibility) so as to ensure that it was brought to a successful and timely completion. Although the scope and locations may change the project described above is fairly typical of the projects that we are involved in.
As part of the project management activities a detailed Validation Master Plan is provided. It describes the activities, roles and responsibilities, and identifies where the process fits within the typical project lifecycle.
Site Acceptance Tests
The SMB Validation & Compliance Services Group can develop Site Acceptance Test protocols to provide evidence that a piece of equipment, system, or integrated process that has been delivered to the end user has not been affected in the transportation and has been adequately tested at the end user’s facility and performed to the end user’s expectations after installation. The SAT document will complete a series of verifications to ensure that what was ordered has been supplied by verifying the original purchase order and all specifications (URS, FRS, DDS) outlined, prior to the manufacture of the equipment, have been respected and incorporated on the installed product.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Factory Acceptance Tests
The SMB Validation & Compliance Services Group can develop Factory Acceptance Test protocols to provide documented evidence that a piece of equipment, system, or integrated process has been adequately tested at the manufacturer’s facility and performed to the end user’s expectations prior to being delivered to the end user. The FAT document will complete a series of verifications to ensure that what was ordered has been supplied by verifying the original purchase order and all specifications (URS, FRS, DDS) outlined, prior to the manufacture of the equipment, have been respected and incorporated on the finished product.
“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”
Standard Operating Procedures
The SMB Validation & Compliance Services Group can prepare Standard Operating Procedures for any critical utility or piece of equipment to provide all personnel working with the equipment information and instructions on what is required in order to maintain, operate, and clean the utility or piece of equipment.
User Requirement Specifications
The SMB Validation & Compliance Services Group can prepare User Requirements Specifications for each critical utility or piece of equipment manufacturing. The User Requirements Specification (URS) specifies the needs of the end user as well as any regulatory requirements. The URS is provided to the supplier in order to ensure that all expected requirements, of the end user, for the utility or piece of equipment have been specified and supplied prior to the actual manufacturing stage.
Functional Requirement Specifications
The SMB Validation & Compliance Services Group can prepare Functional Requirement Specifications (FRS) for each critical utility or piece of equipment manufacturing. The Functional Requirements Specification defines a system to meet the users needs as specified in the User Requirement Specification.
Detailed Design Specifications
The SMB Validation & Compliance Services Group can prepare Detail Design Specifications (DDS) for each critical utility or piece of equipment manufacturing. The DDS follows on from the Functional Requirement Specification and defines the hardware and software of the system, and it’s interfaces to other systems.
Note: Detailed Design Specifications are often divided into Hardware and software specifications.
cGMP & VALIDATION TRAINING
The cGMP Training Program is designed specifically to teach the “language” of the industry and to develop within attendees a good understanding of the requirements and regulations that control the day-to-day activities of a GMP facility.
Module 1: Overview of Regulations and Validation and Documentation Concepts
Goal: Provide a basic understanding of the regulatory framework in place in the Pharmaceutical and Medical Device industry and introduce the participants to basic Validation and Documentation concepts.
This module uses a PowerPoint Presentation and includes the following:
- Objectives of Training Session
- Introduction and Qualifications of Trainer
- Historical review of the evolution of the regulations for Pharmaceutical and Medical Device Manufacturers
- Validation: Some Definitions and Requirements
- Current Validation Practices and Regulations
- Basic Concepts of Documentation Requirements
- Verification of Knowledge Acquisition
This module lasts approximately 3 hours.
Module 2: General cGMP and Equipment Design Topics
Goal: Develop an understanding of GMP design practices in use within the Pharmaceutical and Medical Device Industry.
This module is in the form of a Round Table discussion and includes the following:
- Objectives of Training Session
- GAMP 4 Concepts
- 21 CFR Part 11 Requirements and Implications
- Clean Room and Aseptic Manufacturing Concepts
- General Considerations for Design and Construction of Equipment for the Pharmaceutical and Medical Device manufacturers
- Product Contact Parts Requirements and Practices
- Cleaning Validation Concepts
- Basic Calibration Concepts
- Product Yield and Label Reconciliation Requirements
- Verification of Knowledge Acquisition
This module lasts approximately 3 hours.
Module 3: cGMP Orientation
This module uses a PowerPoint Presentation and includes the following:
- Goal: Develop an understanding of the cGMP’s..
- Objective of Training Session
- Definitions of selected terms used in the Pharmaceutical and Medical Device industry
- Who is responsible for compliance?
- Brief review of regulation history
- The need to document
- Drug Product Production Cycle
- Types of Quality
- Consequence of Non-Compliance
- Verification of Knowledge Acquisition
This module lasts approximately 1/12 hours.
Module 4: Standard Operating Procedures
Goal: Develop an understanding of procedural practices in use within the Pharmaceutical and Medical Device Industry.
This module uses a PowerPoint Presentation and includes the following:
- Objective of Training Session
- What is a Procedure?
- Goal of a Procedure
- When are Procedures used?
- What do Regulatory Agencies expect when looking at Procedures?
- The Notion of Promise with respect to Procedures
- Verification of Knowledge Acquisition
This module lasts approximately 1 hour.
Module 5: Record Keeping and Quality Assurance
Goal: Develop an understanding of Record Keeping practices in use within the Pharmaceutical and Medical Device Industry as well as an understanding for Quality Assurance/Control Procedures and Responsibilities.
This module uses a PowerPoint Presentation and includes the following:
- Objective of Training Session
- Selected Definitions
- Types of Records
- Procedures and Records - The Notion of Promise (Re-Visited)
- Testing Sequence within the Drug Production Cycle
- Who is responsible for quality?
- Verification of Knowledge Acquisition
This module lasts approximately 1 hour.
Module 6: Cost Considerations in Validation
Goal: Develop an awareness of the costs of validation and of the responsibilities of various parties within the Validation Process.
This module uses a PowerPoint Presentation and includes the following:
- Types of Costs
- The Role of the Pharmaceutical or Medical Device Manufacturer
- The Role of the Equipment Designer/Builder
- The Role of the Validation Provider
- Other Costs Considerations
- Verification of Knowledge Acquisition
This module lasts approximately 1 hour.
|
News, Events, Validation Master Plans, IQ, OQ, PQ, 21 CFR Part 11 gap analysis, Summary Reports, CSV, GXP, GMP, cGMP, GAMP4, SOP’s, URS, FRS, URS and DDS Generation for all packaging and processing equipment
| | | | | | © SMB Validation & Compliance Services Group Inc, SMB Group, SMBValidation. - |
