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Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evalua... Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 Effective 05/26/2022 This solicitation is not set-aside, it is unrestricted, full and open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 611430, with a small business size standard of $12.0M. The FSC/PSC is AN11. The New Mexico VA Healthcare System is seeking to purchase Good Manufacturing Practices (GMP) Training for Pharmaceuticals. All interested companies shall provide quotations for the following: See Attachment A, Item Information STATEMENT OF WORK (SOW) OBJCTIVE. Current Good Manufacturing Practice (GMP) Training for Pharmaceuticals. BACKGROUND. The Clinical Research Pharmacy Coordinating Center, a Registered Drug Establishment, within the VA Cooperative Studies Program is subject to the Food and Drug Administration regulations under Title 21 of the Code of Federal Regulations (CFR) for the manufacturing, packaging, holding and distribution of pharmaceutical products. Section 211.25 specifies training in Good Manufacturing Practice (GMP) is required on a continuing basis and at specified intervals to ensure all employees involved in cGMP activities are current and knowledgeable in these practices. SCOPE. This requirement is for a Base Year plus Four (4) Option Years. Vendor will provide a web-based training curriculum designed to train approximately 115 employees involved in a broad range of responsibilities within a Good Manufacturing Practice (GMP) compliant pharmaceutical manufacturing organization. Curriculum must be based upon a complete treatment of the different subparts of FDA regulations under 21 CFR Part 211, with emphasis on quality assurance, quality control and corrective and preventative actions (CAPAs). Training modules should be established so supervisors can select specific modules relevant to their subordinates. All employees will take the most basic topics while various groups will require applicable additional topics. And there needs to be enough available modules that employees are not taking 100 percent of the same modules every year of the contract. REQUIREMENTS. 4.1 Training audience consists of the following groups (and maximum number of persons involved): a. Production/Drug Handling Manufacturing, packaging, kitting and labeling staff with direct and frequent contact with drug products, API s, excipients and components or medical devices (25). b. Technical support individuals who provide indirect support to manufacturing, packaging, labeling, or warehousing of drug components or medical devices, including software development and IT support (20). c. Study management Pharmacists and pharmaceutical project managers who design, direct, and implement clinical trials (25). d. Administrative, non cGMP this includes a variety of administrative and support personnel who have no direct contact with drugs or devices and require a general understanding of cGMP and the reasons these regulations must be followed (35). e. Lab & QC includes analytical chemists, laboratory assistants and Quality Control personnel who analyze drug products or enforce the cGMP regulations for identity, quality, purity, and strength (10). 4.2 All Learners will be required to successfully complete 5 contact-hours or courses per year, except for the non-cGMP Group (Administrative) who will require a minimum of 2 contact-hours or courses per year. Learners shall have the flexibility to select the appropriate courses or topics from a catalog of course offerings to specifically address their job-specific cGMP training needs. 4.3 Training curriculum shall provide a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for pharmaceutical products, including the following areas of focus: a. Building and Facilities b. Control of Components c. Drug Product Containers and Closures d. Holding and Distribution e. Production and Process Controls f. Packaging and Labeling Control g. Records and Reports h. Organization and Personnel i. Equipment j. Returned and Salvaged Drug Products. 4.4 The key outcome for students taking this curriculum will be gaining the knowledge and skills to successfully contribute within a GMP-compliant drug manufacturing environment by achieving a strong understanding of these FDA codes, industry regulations, standards, and the practices required to perform within the federal regulations to maintain compliance. 4.5 Training courses offered shall provide a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for pharmaceutical products. Specific assignment of courses to Learners will be determined by Section Chiefs with guidance by the Chief, QC to meet job-specific requirements. At a minimum, the following topics shall be included: a. An Introduction to Good Manufacturing Practice (GMP) b. GMP in the Warehouse c. Microbiology in the Workplace d. Cleaning and Sanitation e. Documentation and Record Keeping (GDocP) f. Contamination Control g. Production Controls h. Packaging Controls i. Quality Assurance and Quality Control (QA/QC) j. Good Laboratory Practice (GLP) k. Corrective Actions and Preventative Actions (CAPAs). 4.6 After completing training, students should be able to explain the principles of current good manufacturing practice (cGMP) and its importance within a regulated pharmaceutical manufacturing environment. 4.7 In addition to the general population, Laboratory and Quality Control personnel require additional areas with some job-specific training in cGMP regulations as they apply to pharmaceutical laboratory procedures, and how such practices lead to the creation of technically defendable scientific data, by which its quality, reliability, and trustworthiness can be assured. This curriculum shall provide the necessary knowledge and skills to ensure that attendees can fully integrate data integrity into laboratory quality management systems, thus ensuring that all scientific data delivered by analytical testing laboratories is both reliable and trustworthy. This curriculum shall examine formal laboratory audits from the perspective of the laboratory being audited. By the end of this program students will be able to explain the different approaches the auditor can follow during an audit, the things the auditor will be looking for during a typical laboratory audit, an overview of a strategy the laboratory can use to handle audits, what the laboratory can do to prepare for the audit, how to handle the progress of an audit, how to follow up after completion of an audit and what constitutes obstructing regulatory audits. 4.8 On completion of this additional program, students will be able to explain the elements of a meaningful laboratory investigation, define commonly used terms related to laboratory investigations, discuss the applicable cGMP/cGLP regulations and guidance related to laboratory investigations, explain the details and significance of the Barr Decision as it relates to laboratory investigations in a cGMP/cGLP environment and explain the detailed procedure for all phases of conducting and documenting a laboratory investigation. 4.9 Vendor shall provide a Training Manager Portal to enroll students, access training records and certifications (including Excel Download), and view student accounts and statistics. Courses shall be SCORM-compliant, and compatible with industry-standard learning management systems (LMSs). Accounts and logon access for a limited number of Training Managers shall be provided each year for the purposes of enrolling employees into courses for one (1) year of access, view training status and statistics for defined cohorts of employees, and to download training reports and certificates. SECURITY REQUIREMENTS. The C&A requirements do not apply, and that a Security Accreditation Package is not required. PLACE OF PERFORMANCE. Training will be provided via online system. PERIOD OF PERFORMACE. Period of Performance is for a Base Year and four (4) option years after contract award: Base Year: CLIN Description Qty Unit Unit Price Extended Cost 0001 Group 1: Production/Drug Handling 25 LT 0002 Group 2: Technical Support 20 LT 0003 Group 3: Study Management 25 LT 0004 Group 4: Administrative, non-cGMP 35 LT 0005 Group 5: Lab & QC 10 LT TOTAL Option Year One (1) CLIN Description Qty Unit Unit Price Extended Cost 1001 Group 1: Production/Drug Handling 25 LT 1002 Group 2: Technical Support 20 LT 1003 Group 3: Study Management 25 LT 1004 Group 4: Administrative, non-cGMP 35 LT 1005 Group 5: Lab & QC 10 LT TOTAL Option Year Two (2) CLIN Description Qty Unit Unit Price Extended Cost 2001 Group 1: Production/Drug Handling 25 LT 2002 Group 2: Technical Support 20 LT 2003 Group 3: Study Management 25 LT 2004 Group 4: Administrative, non-cGMP 35 LT 2005 Group 5: Lab & QC 10 LT TOTAL Option Year Three (3) CLIN Description Qty Unit Unit Price Extended Cost 3001 Group 1: Production/Drug Handling 25 LT 3002 Group 2: Technical Support 20 LT 3003 Group 3: Study Management 25 LT 3004 Group 4: Administrative, non-cGMP 35 LT 3005 Group 5: Lab & QC 10 LT TOTAL Option Year Four (4) CLIN Description Qty Unit Unit Price Extended Cost 4001 Group 1: Production/Drug Handling 25 LT 4002 Group 2: Technical Support 20 LT 4003 Group 3: Study Management 25 LT 4004 Group 4: Administrative, non-cGMP 35 LT 4005 Group 5: Lab & QC 10 LT TOTAL The task order period of performance is 09/01/2022 08/31/2027 Place of Performance/Place of Delivery Address: Department of Veterans Affairs Postal Code: New Mexico VA Healthcare System 1501 San Pedro Dr, SE Albuquerque, NM 87108 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items FAR 52.212-3, Offerors Representations and Certifications Commercial Items Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items May 2022 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders May 2022 All quoters shall submit the following: A quote for the base year and all option years. Each individual Contract Line Item (CLIN) must be priced. Lump sum pricing is not allowed. All quotes shall be sent to: timothy.garrity@va.gov Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. Options are applicable. Contract award will be based on price only of all CLINs on the base year, and all CLINs on all Option Years. The following are the decision factors: Price only The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received via email only not later than 3:00 PM PST on August 12, 2022 at timothy.garrity@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Timothy L. Garrity Contracting Officer Timothy.garrity@va.gov (480) 466-7937 Attachments: Attachment A: Item information Attachment B: Delivery Schedule Attachment C: Clauses and Provisions Attachment D: New Vendor Info