[Link].
Instructions/Questions
1 General Controls
Does the facility and its many departments (organizational units) operate according to controls as defined by
the GMP regulations?
1.1 Organizational & Management Responsibilities
1.1.1 Does Vitabiotics Co. operate under a facility or corporate quality policy?
1.1.2 Does a Quality Excellency head exist as a separate organizational entity & reported to CEO or GM?
1.1.3 Does the Operational Quality department alone have both the authority and responsibility to approve or reject
all components, drug product containers and closures, in-process materials, packaging materials, labeling and
drug products?
1.1.4 Does the Operational Quality department routinely review production records to ensure that procedures were
followed and properly documented?
1.1.5 Dose the Compliance department have both the authority and responsibility to keep the process comply with
cGMP through risk assessment, change control, CAPA & self-inspection?
1.1.6 Dose the validation section have both the authority and responsibility to valid all process & qualify all
machines which are affected to the product quality?
1.1.7 Are adequate laboratory space, equipment, and qualified personnel available for required testing?
1.1.8 If any portion of testing is performed by a contractor, has the Compliance department inspected the
contractor's site and verified that the laboratory space, equipment, qualified personnel and procedures are
adequate?
1.1.9 Are Operational Quality & Compliance supervisory personnel qualified by way of training and experience?
1.1.10 Are organization of departments clear & job discerptions full fill all company needs & objectives?
1.1.11 There are KPIs for annual evaluation according to cGMP, Admin guides & Co. policy?
1.1.12 What is the level of executions? Doer □
Doer & Checker □
Doer, Checker & approval □
1.2 Employee Orientation, Quality Awareness, and Job Training
Circle the types of orientation provided to each new employee:
(1) Company brochure
(2) Literature describing GMP regulations and stressing importance of instructions.
1.2.1
(3) On-the-job training for each function to be performed (before the employee is allowed to perform such
tasks).
(4) Data integrity concepts & 5S attitudes
1.2.2 Does each employee receive retraining on an SOP or instruction if critical changes have been made in it?
1.2.3 Indicate how on-going, periodic GMP training is accomplished.
1.2.4 Are supervisory personnel instructed to prohibit any employee who, because of any physical condition (as
determined by medical examination or supervisory observation) that may adversely affect the safety or quality
of drug products, from coming into direct contact with any drug component or immediate containers for
finished product?
1.3 Plant Safety and Security
1.3.1 Does this facility have a facility or corporate safety program?
1.3.2 Are safety procedures written?
1.3.3 Are safety procedures current?
1.3.4 Do employees receive safety orientation before working in the plant area?
1.3.5 Is safety training documented in a readily retrievable manner that states the name of the employee, the type of
training, the date of the training, and the name of the trainer and the signature of the trainer and the
participant?
1.3.6 Does this facility have a formal, written security policy?
1.3.7 Is access to the facility restricted?
1.3.8 Describe how entry is monitored/restricted:
1.3.9 Is a security person available 24 hours per day?
[Link]. Instructions/Questions
1.4 Quality Cost Program
1.4.1 Does this facility have a periodic and formal review of the cost of quality?
Does this facility have the ability, through personnel, software, and accounting records, to identify and capture
1.4.2
quality costs?
1.4.3 Does this facility make a conscious effort to reduce quality costs?
2.0 Facility Control
2.1 Facility Design and Layout
Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and
2.1.1
holding of drug products?
2.1.2 Is there sufficient space in the facility for the type of work and typical volume of production?
2.1.3 Does the layout and organization of the facility prevent contamination?
2.2 Environmental Control Program
The facility is NOT situated in a location that potentially subjects workers or product to particulate matter,
2.2.1
fumes, or infestations?
2.2.2 Is lighting adequate in all areas?
2.2.3 Is adequate ventilation provided?
2.2.4 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or
testing of drug products?
2.2.5 If air filters are used, is there a written procedure specifying the frequency of inspection and replacement?
2.2.6 Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility?
2.2.7 Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY
IF HAZARD IS PRESENT!)
2.3 Facility Maintenance and Good Housekeeping Program
2.3.1 Is this facility free from infestation by rodents, birds & insects?
2.3.2 Does this facility have written procedures for the safe use of suitable, (e.g. those that are properly registered)
rodenticides, insecticides, fungicides, and fumigating agents?
2.3.3 Is this facility maintained in a clean and sanitary condition?
2.3.4 Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods,
equipment and material?
2.3.5 Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents?
2.3.6 Are all parts of the facility maintained in a good state of repair?
2.3.7 Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?)
2.4 Outsourcings Control Program
2.4.1 Are outsourcings and temporary employees required to perform their work under sanitary conditions?
Are outsourcings qualified by experience or training to perform tasks that may influence the production,
2.4.2
packaging, or holding of drug products?
3.0 Equipment Control
3.1 Equipment Design and Placement
Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its
3.1.1
intended use?
3.1.2 Are the following pieces of equipment suitable for their purpose? e.g., Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify).
3.1.3 Are the following pieces of equipment suitable in their size/capacity? e.g., Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify).
3.1.4 Are the following pieces of equipment suitable in their design? e.g., Blender(s), Conveyor(s), Tablet, Presses,
Capsule Fillers, Bottle Fillers, Other (specify).
3.1.5 Are the locations in the facility of the following pieces of equipment acceptable? e.g., Blender(s),
Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify).
3.1.6 Are the following pieces of equipment properly installed? e.g., Blender(s), Conveyor(s), Tablet, Presses,
Capsule Fillers, Bottle Fillers, Other (specify).
3.1.7 Is there adequate space for the following pieces of equipment? e.g., Blender(s), Conveyor(s), Tablet, Presses,
Capsule Fillers, Bottle Fillers, Other (specify).
[Link]. Instructions/Questions
3.1.8 Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-additive
so as not to affect the product?
3.1.9 Are design and operating precautions taken to ensure that lubricants or coolants or other operating substances
do NOT come into contact with drug components or finished product?
3.1.10 Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly
cleaned?
3.2 Equipment Qualification Program
Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of
3.2.1
producing valid results.
3.2.2 When computers are used to automate production or quality testing, have the computer and software been
validated?
3.2.3 Have on-site tests of successive production runs or tests been used to qualify equipment?
3.2.4 Were tests repeated a sufficient number of times to ensure reliable results?
3.2.5 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum
operating speeds for valid results?
3.2.6 Have performance characteristics been identified for each piece of equipment? (May be provided by the
manufacturer, but must be verified under typical operations conditions.)
3.2.7 Have operating limits and tolerances for performance been established from performance characteristics?
4.0 Material/Component Control
4.1 Material/Component Specification and Purchasing Control
Has each supplier/vendor of material or component been inspected/audited for proper manufacturing controls?
4.1.1
(Review suppliers and audits and enter names, material supplied, and date last audited in notebook.)
4.1.2 Is purchasing department stick to approved suppliers list?
4.1.3 Is production plan performed according to forecast?
4.2 Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
Does the facility have current written procedures for acceptance/rejections of drug products, containers,
4.2.1 closures, labeling and packaging materials? (List selected materials and components in notebook and verify
procedures.)
Is each lot within each shipment of material or components assigned a distinctive code so material or
4.2.2
component can be traced through manufacturing and distribution?
Does inspection start with visual examination of each shipping container for appropriate labeling, signs of
4.2.3
damage, or contamination?
Material Component Storage and Handling
4.3
(Verify that materials and components are stored and handled in a way that prevents contamination, mix-ups,
and errors.)
4.3.1 Are incoming material and components quarantined until approved for use?
4.3.2 Are all materials handled in such a way to prevent contamination?
4.4 Inventory Control Program
4.4.1 Are inventory control procedures written?
4.4.2 Does the program identify destruction dates for obsolete or outdated materials, components, and packaging
materials?
4.4.3 Is stock rotated to ensure that the oldest approved product or material is used first?
4.4.4 Is destruction of materials documented in a way that clearly identifies the material destroyed and the date on
which destruction took place?
4.5 Vendor (Supplier) Control Program
4.5.1 Are vendors periodically inspected according to a written procedure?
4.5.2 Is the procedure for confirming vendor test results written and followed?
5.0 Operational Control
5.1 Material/Component/Label Verification, Storage, and Handling
Do written procedures identify storage time beyond which components, containers, and closures must be
5.1.1
reexamined before use?
5.1.2 Is release of retested material clearly identified for use?
5.1.3 Do written procedures identify steps in the dispensing of material for production?
[Link]. Instructions/Questions
5.2 Operational Process Validation and Production Change Order Control
Have production procedures been validated? (Review selected procedures for validation documentation.
5.2.1
Adequate?)
5.2.2 Does the process control address all issues to ensure identity, strength, quality and purity of product?
5.2.3 Does the procedure include formulation that is written to yield not less than 100% of established amount of
active ingredients?
5.3 In-Process Inspection, Sampling, and Laboratory Control
5.4 Finished Product Verification, Storage, and Handling
5.5 Finished Product Inspection, Sampling, Testing, and Release for Distribution
5.6 Distribution Controls
5.7 Marketing Controls
5.8 Complaint Handling and Customer Satisfaction Program
6.0 Product registration documents & studies
7.0 CTD files requirements