G-103
Qualification of Equipment
Original Document
Scanned document (image-only PDF)
Extracted Text
Searchable text extracted from PDF
1.0 Purpose The purpose of this procedure is to describe the process for qualifying equipment for use in manufacturing of dietary supplements and pet products to ensure that the equipment functions properly, in accordance with its intended use, and will consistently provide expected results per 21 CFR Part 111. 2.0 Scope This procedure applies to all equipment used in the manufacturing of dietary supplements and pet products at Ion Labs. This does not apply to the qualification of QC laboratory analytical equipment. 3.0 Responsibility 3.1 Operations, Maintenance, Quality, R&D, Safety, and AD personnel are responsible for following this procedure, executing qualification checklists, and for assessing any changes to qualified equipment for requalification. 3.2 Quality Management is responsible for maintaining this procedure and reviewing and approving qualification checklists. 4.0 Definitions 4.1 IQ — Installation Qualification; the process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification. 4.2 OQ -— Operational Qualification; the process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures. [SOP Q S u t a a l n i d f a i r c d a O t p i e on r a o t f i n E g q u Pr i o p c m e e d n u t re S G O - P 1 0 N 3 o R 3 e v — age 2 of 5 4.3 PQ — Performance Qualification; the process of establishing by objective evidence that the equipment consistently produces a product which meets all predetermined requirements. 4.4 PPE — Personal Protective Equipment 4.5 QC — Quality Control 4.6 R&D — Research and Development 4.7 DC — Document Control 4.8 AD — Analytical Development 4.9 PM — Preventative Maintenance 5.0 References 5.1 C-502, SOP, Record Storage, Retention, and Destruction Ose G-102, SOP, Equipment Profiles 5.3 G-201, SOP, Calibration Program 5.4 G-103-F1, Form, Installation and Operation Qualification Checklist 6.0 Rationale 6.1 The overall goal of qualification is to ensure all items used in the production and analysis of product is appropriate for its designated use, is in satisfactory working condition and will perform as specified. 7.0 Procedure for New Equipment Note: IQOQ checklists are not required for all pieces of equipment. They are intended for large pieces of manufacturing equipment, such as tablet presses, blenders, etc. [SOP Standard Operating Procedure SOP No Rev G-103 Page 3 of 5 Qualification of Equipment 7.1 DC will assign an equipment number per SOP G-102 Equipment Profiles. Maintenance or Production personnel will complete Form G-102-F1 Equipment Profile. QC Laboratory personnel will enter the equipment into the calibration program per SOP G- 201 Calibration Program. 7.2 For new equipment that requires IQOQ to be performed, the following minimum requirements must be assessed: 7.2.1 Operational Requirements 7.2.1.1 Are copies of the manufacturer’s operating and maintenance instructions available? 7.2.1.2 Are all operating controls properly labeled? 7.2.1.3 Is a procedure required for use? If so, is one available and current? 7.2.1.4 How often does a PM need to be performed on this item? What does the PM consist of? 7.2.1.5 Are there temperature or humidity requirements for the installation location? 7.2.1.6 Isa sink/water required in the vicinity of use? 7.2.2 Electrical Requirements 7.2.2.1 What are the electrical requirements of this item? 7.2.2.2 Is the requirement met with current capacity? 7.2.2.3 Are all wiring rated for power draw? 7.2.2.4 Is item properly grounded? 7.2.3. Safety 7.2.3.1 Is the item properly installed per manufacturer recommendations? [SOP Standard Operating Procedure SOP No Rev as Qualification of Equipment G-103 3 age 40 7.2.3.2 Are employees protected from any exposure to moving parts? 7.2.3.3 Are there any necessary warnings required? If so, are they in conspicuous locations and clearly marked 7.2.3.4 Does the operation, maintenance, or cleaning of the item require hazardous chemicals? 7.2.3.5 Does the operation, maintenance, or cleaning of the item require PPE? If so, what is the PPE needed? 7.2.4 Access 7.2.4.1 Does layout prevent workers from awkward positions during operation? 7.2.4.2 Does layout prevent workers from applying appropriate force during adjustments, changeovers, etc.? 7.2.4.3 Does layout provide a safe operational zone for all operation and maintenance personnel? 7.2.5 Control 7.2.5.1. Can all disconnects and power controls be locked out? 7.2.5.2 Are these controls/ emergency stops/ cords/ cables in easily accessible locations? 7.2.5.3 Have all energy control devices, switches, interlocks, sensors, e-stops, been tested while machine is in operations? 7.2.5.4 Do these items perform their intended function? 7.2.6 Others 7.2.6.1 If other requirements are necessary, they should be listed on the form as well. [SOP Standard Operating Procedure SOP No Rev G-103 Page 5 of 5 Qualification of Equipment 7.3. If new equipment or initial qualification, the responsible group, with assistance from R&D or AD groups and Safety, will complete Form G-103-F1 Installation and Operational Qualification (IOQ) Checklist for the equipment and forward to appropriate Operations or R&D/AD personnel. (ey Operations or Maintenance personnel will refer to the manufacturer’s recommendations (e.g. temperature and humidity, utilities, etc.), any equipment literature available (i.e. User manual, product bulletin, manufacturer photos, etc.) and view actual equipment to populate Sections I and II. Ensure items listed are adequate to verify that the equipment functions properly, and in accordance with its intended use, per 21 CFR Part 111. Forward to Quality once complete. 8.0 Documentation Maintenance 8.1 Installation and Operational Qualification checklists will be filed and maintained with the Equipment Profile associated with its piece of equipment. 8.2 Documentation will be maintained per SOP C-502 Record Storage, Retention, and Destruction. 9.0 Revision History | Rev | Date | Description of Changes | CCR # | By | |-----|----------|------------------------|-------|----| | 0 | 05/22/14 | New 03/24/15 Revise for clarification 15-0056 D. Popp | 14-0442 | D. Popp | | 2 | 12/23/19 | Scheduled review: revised for completeness. | 19-0967 | J. Maignan | | 3 | 08/08/22 | Scheduled review: updated logo and formatting. Added CC- documentation maintenance requirements. Added definitions. | 22-0346 | K. Burris | [SOP Installation and Operational Qualification (IOQ) Checklist igorSN Ls Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Confirmation of Equipment Received as Purchased Ion PO number: Order date: Vendor order number: Shipping date: Equipment order and shipping paperwork match: LI] Verified LJ No Match Physical receipt confirmation Equipment received is as ordered: LI Verified L] No Match Comments: Performed by: Date: Confirmation of receipt of packing list items Confirm receipt of all items listed on the packing slip. All items are received: [| Yes [| No Confirmed packing slip is attached: [| Yes [| No Comments: Performed by: Date: [SOP Installation and Operational Qualification (IOQ) Checklist gga SOS Beet “ee Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Equipment Identification Equipment Name: Model: Serial number: Ion #: Firmware revision: Component Name Model # Serial # Ion # Component Identification Component Name Model # Serial # Ion # Component Identification Component Name Model # Serial # Ion # Component Identification Component Name Model # Serial # Ion # Comments: Performed by: Date: [SOP Installation and Operational Qualification (IOQ) Checklist gga SON Bee S Beret see’ Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Installation Requirements Verification Building: Room: Comments: Performed by: Date: Is a copy of the manufacturer’s operating manual available? LC] Yes [] No LI] N/A Room temperature and humidity meet specifications in operating manual? LC] Yes L] No L] N/A Is water source needed? L] Yes LI] No LI N/A If so, is it available? L] Yes [] No L] N/A Area free of potential vibration problems L] Yes L] No L] N/A Is area properly ventilated? LI] Yes L] No LI N/A What are the electrical requirements of this item? Is the requirement from above met? LI] Yes L] No LI N/A Is item properly grounded or double insulated per NEC? [] Yes [] No LI] N/A Is there an SOP required for use? L] Yes Ll] No L] N/A Is the SOP available? [11 Yes | OO No LI N/A Is the SOP current? [11 Yes | OO No LI N/A Is wiring rated for power draw? LI Yes L] No LI N/A Does the operation, maintenance and cleaning require PPE? [] Yes [1] No [L] N/A If so, what is the PPE needed? Comments: Performed by: Date: [SOP Installation and Operational Qualification (IOQ) Checklist :SGIIIS % ,ocew a.so hg %er*y W% EEL gniL srewoB Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Other Considerations If other considerations are required, please notate them on this page. [SOP Installation and Operational Qualification (IOQ) Checklist :SGIIIS % ,ocew a.so hg %er*y W% EEL gniL srewoB Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Installation Qualification Certification Installation of this item (Ion #: ) has been performed according to the guidelines established by the manufacturer and set down in this section describing instrument installation. Comments: Performed by: Date: Installation Qualification has been performed, reviewed, and approved according to the guidelines established by the manufacturer and set down in this section describing instrument installation. All results, having met the specified parameters, hereby certify the above item as having been properly installed. Comments: Approved by: Date: [SOP Installation and Operational Qualification (IOQ) Checklist Agee SNE Rd Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 OQ Defined Operation qualification (OQ) is defined as documented verification that all key aspects of equipment operation meet the manufacturer’s established specifications throughout a representative or anticipated operating range. Equipment, Component, and Location Identification Model: Serial Number: Ion # Number of Components.: Component Identification Component Name Model # Serial # Ion # Component Identification Component Name Model # Serial # Ion # Component Identification Component Name Model # Serial # Ion # Component Identification Component Name Model # Serial # Ion # Comments: Performed by: Date: [SOP Installation and Operational Qualification (IOQ) Checklist :SGIIIS % ,octf tsag%eerpyt‘ "an fiS“ srewoB Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Certificates In the table below, list all certificates/manuals/paperwork associated with this item. Comments: Performed by: Date: [SOP Installation and Operational Qualification (IOQ) Checklist AgeeSNE Rd Form: G-103-F1 CCR No. CC-22-0346 Revision: 4 Are all operating controls properly labeled? oO Yes oO No oO N/A How often does PM need to be performed on this item? What are the requirements of the PM Is item installed per manufacturer recommendations? C] Yes [1 No CI N/A Are employees protected from exposure to moving parts? C] Yes [1 No CI N/A Are there any necessary warnings required? CI Yes [] No CI N/A Are they posted in conspicuous locations and clearly marked? C1 Yes [] No CI N/A Does the operation, maintenance or cleaning of the item require hazardous chemicals LJ Yes LI No LI N/A Is the electrical draw while being used under normal conditions sufficient? If item is product contact, are all components that could contact product stainless steel of food grade materials? LI Yes LI No LI N/A Is the item as installed, provide conditions for safe use, cleaning and maintenance? LI Yes LI No LI N/A Is operating, cleaning or maintenance going to require or produce hazardous waste or hazardous environmental conditions? : U1 Yes LI No LI N/A Can all disconnects and power controls be locked out? : L] Yes L] No CI N/A What are the emergency control items? Are all control/emergency stops/ cords/ cables easily accessible? C Yes No Ona Do each of the items listed above perform their intended function C1 Yes No Gf possible check each while in operation)? : LI N/A What is the purpose of this item? D ab o o e v s e ? th e : item after installation perform the function listed LJ Yes LI No [| N/A Is training required for this item? LI] Yes LI No CI N/A Performed by: Date: