Pharmaceutical GMP Audit Checklist

28 Jun 2023 / Herman Lucio Complete

Score 98.89% Flagged items 2 Actions 1

Site conducted Unanswered

Conducted on 28 Jun 2023 09:34 PST

Prepared by Herman Lucio

Ayala Avenue
Bel Air, Makati City
1209 Metro Manila
Location
Philippines
(14.556748580023427,
121.02127404322115)
1.Flaggeditems&Actions

Flagged items & Actions 2 flagged, 1 action

Flagged items 2 flagged, 1 action

General Controls / Organizational & Management Responsibilities

Does a Quality Assurance unit (department) exist as a

No
separate organizational entity?

Currently not yet. Will request for this to be prioritized ASAP.

To Do | Priority High | Due 5 Jul 2023 09:58 PST | Created by SafetyCulture Staff

Prioritize creation of QA unit

General Controls / Organizational & Management Responsibilities

Does the Quality Assurance unit alone have both the

authority and responsibility to approve or reject all
No
components, drug product containers and closures, in-process
materials, packaging materials, labeling and drug products?

Other actions 0 actions

2.GeneralControls-95.46%

General Controls 2 flagged, 1 action, 95.46%

2.1.Organizational&ManagementResponsibilities-83.33%

Organizational & Management 2 flagged, 1 action, 83.33%

Responsibilities

Does this facility/business unit operate under a facility or

Yes
corporate quality policy?

Does a Quality Assurance unit (department) exist as a

No
separate organizational entity?

Currently not yet. Will request for this to be prioritized ASAP.

To Do | Priority High | Due 5 Jul 2023 09:58 PST | Created by SafetyCulture Staff

Prioritize creation of QA unit

Does the Quality Assurance unit alone have both the

authority and responsibility to approve or reject all
No
components, drug product containers and closures, in-process
materials, packaging materials, labeling and drug products?

Does the QA department or unit routinely review production

records to ensure that procedures were followed and properly Yes
documented?

Are adequate laboratory space, equipment, and qualified

Yes
personnel available for required testing?

If any portion of testing is performed by a contractor, has the

Quality Assurance unit inspected the contractor’s site and
Yes
verified that the laboratory space, equipment, qualified
personnel, and procedures are adequate?

Are all QA procedures in writing? Yes

Are all QA responsibilities in writing? Yes

Are all written QA procedures current and approved? (Review

Yes
log of procedures)

Are the procedures followed? (Examine records to ensure

consistent record- keeping that adequately documents Yes
testing.)

Are QA supervisory personnel qualified by way of training and

N/A
experience?

"Are other QA personnel, e.g., chemists, analysts, laboratory

Yes
technicians)

qualified by way of training and experience?" Yes

2.2.DocumentControlProgram-100%
 Document Control Program 100%

Does the QA unit have a person or department specifically

charged with the responsibility of designing, revising, and
Yes
obtaining approval for production and testing procedures,
forms, and records?

Does a written SOP, which identifies how the form is to be

completed and who signs and countersigns, exist for each Yes
record or form?

Is the production batch record and release test results

reviewed for accuracy and completeness before a batch/lot of Yes
finished product is released?
2.3.EmployeeOrientation,QualityAwareness,andJobTraining-100%

Employee Orientation, Quality Awareness, 100%

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 following
Yes
instructions. (3) On-the-job training for each function to be
performed (before the employee is allowed to perform such
tasks). (4) Other: enter in notebook.

Does each employee receive retraining on an SOP

(procedures) if critical changes have been made in the Yes
procedure?

Indicate how on-going, periodic GMP training is accomplished.

There are monthly trainings for GMP compliance done in the SafetyCulture app and all data is
forwarded to the right leaders for tracking. Even if there are no changes in procedures, this is
done.

Is all training documented in writing that indicates the date

of the training, the type of training, and the signature of both Yes
the employee and the trainer?

Are training records readily retrievable in a manner that

enables one to determine what training an employee has
Yes
received, which employees have been trained on a particular
procedure, or have attended a particular training program?

Are GMP trainers qualified through experience and training? Yes

Are supervisory personnel instructed to prohibit any

employee who, because of any physical condition (as
determined by medical examination or supervisory
Yes
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?
 Are employees required to report to supervisory personnel
any health or physical condition that may have an adverse Yes
effect on drug product safety and purity?

Are temporary employees given the same orientation as

Yes
permanent employees?

Are consultants, who are hired to advise on any aspect of

manufacture, processing, packing or holding, of approval for
Yes
release of drug products, asked to provide evidence of their
education, training, and experience?

Are written records maintained stating the name, address,

qualifications, and date of service for any consultants and the Yes
type of service they provide?
2.4.PlantSafetyandSecurity-100%

Plant Safety and Security 100%

Does this facility have a facility or corporate safety program? Yes

Are safety procedures written? Yes

Are safety procedures current? Yes

Do employees receive safety orientation before working in

Yes
the plant area?

Is safety training documented in a readily retrievable manner

that states the name of the employee, the type of training,
Yes
the date of the training, and the name of the trainer and the
signature of the trainer and the participant?

Does this facility have a formal, written security policy? Yes

Is access to the facility restricted? Yes

Describe how entry is monitored/restricted: Yes

Is a security person available 24 hours per day? Yes

2.5.InternalQuality/GMPAuditProgram-100%

Internal Quality/GMP Audit Program 100%

Does this business unit/facility have a written quality policy? Yes

Is a copy of this quality policy furnished to all employees? Yes

Is training provided in quality improvement? Yes

Does a formal auditing function exist in the Quality Assurance

Yes
department?
 Does a written SOP specify who shall conduct audits and
qualifications (education, training, and experience) for those Yes
who conduct audits?

Does a written SOP specify the scope and frequency of audits

Yes
and how such audits are to be documented?

Does a written SOP specify the distribution of the audit

Yes
report?
2.6.QualityCostProgram-100%

Quality Cost Program 100%

Does this facility have a periodic and formal review of the cost
Yes
of quality?

Does this facility have the ability, through personnel,

software, and accounting records, to identify and capture Yes
quality costs?

Does this facility make a conscious effort to reduce quality

Yes
costs?
3.FacilityControl-100%

Facility Control 100%

3.1.FacilityDesignandLayout-100%

Facility Design and Layout 100%

Are all parts of the facility constructed in a way that makes

them suitable for the manufacture, testing, and holding of Yes
drug products?

Is there sufficient space in the facility for the type of work and
Yes
typical volume of production?

Does the layout and organization of the facility prevent

Yes
contamination?
3.2.EnvironmentalControlProgram-100%

Environmental Control Program 100%

The facility is NOT situated in a location that potentially

subjects workers or product to particulate matter, fumes, or Yes
infestations?

Are grounds free of standing water? Yes

Is lighting adequate in all areas? Yes

Is adequate ventilation provided? Yes

Is control of air pressure, dust, humidity and temperature

adequate for the manufacture, processing, storage or testing Yes
of drug products?

If air filters are used, is there a written procedure specifying

Yes
the frequency of inspection and replacement?

Are drains and routine cleaning procedures sufficient to

Yes
prevent standing water inside the facility?

Does the facility have separate air handling systems, if

required, to prevent contamination? (MANDATORY IF Yes
PENICILLIN IS PRESENT!)
3.3.FacilityMaintenanceandGoodHousekeepingProgram-100%

Facility Maintenance and Good 100%

Housekeeping Program

Is this facility free from infestation by rodents, birds, insects

Yes
and vermin?

Does this facility have written procedures for the safe use of
suitable, (e.g. those that are properly registered) rodenticides, Yes
insecticides, fungicides, and fumigating agents?
 Is this facility maintained in a clean and sanitary condition? Yes

Does this facility have written procedures that describe in

sufficient detail the cleaning schedule, methods, equipment, Yes
and material?

Does this facility have written procedures for the safe and
Yes
correct use of cleaning and sanitizing agents?

Are all parts of the facility maintained in a good state of

Yes
repair?

Is sewage, trash and other refuse disposed of in a safe and

Yes
sanitary manner (and with sufficient frequency?)
3.4.OutsideContractorControlProgram-100%

Outside Contractor Control Program 100%

Are contractors and temporary employees required to

Yes
perform their work under sanitary conditions?

Are contractors qualified by experience or training to perform

tasks that may influence the production, packaging, or Yes
holding of drug products?
4.EquipmentDesignandPlacement-100%

Equipment Design and Placement 100%

4.1.DesignandPlacement-100%

Design and Placement 100%

Is all equipment used to manufacture process or hold a drug

Yes
product of appropriate design and size for its intended use?

Are machine surfaces that contact materials or finished goods

non- reactive, non-absorptive, and non-additive so as not to Yes
affect the product?

Are design and operating precautions taken to ensure that

lubricants or coolants or other operating substances do NOT Yes
come into contact with drug components or finished product?

Fiber-releasing filters are NOT used in the production of

Yes
injectable products?

Asbestos filters are NOT used in the production of products? Yes

Is each idle piece of equipment clearly marked ""needs

Yes
cleaning"" or ""cleaned; ready for service""?"

Is equipment cleaned promptly after use? Yes

Is idle equipment stored in a designated area? Yes

Are written procedures available for each piece of equipment

used in the manufacturing, processing or holding of Yes
components, in-process material or finished product?

Do cleaning instructions include disassembly and drainage

procedure, if required, to ensure that no cleaning solution or Yes
rinse remains in the equipment?
4.2.EquipmentIdentification-100%

Equipment Identification 100%

Are all pieces of equipment clearly identified with easily

Yes
visible markings?

Are all pieces of equipment also marked with an identification

Yes
number that corresponds with an entry in an equipment log?

Does each piece of equipment have written instructions for

Yes
maintenance that includes a schedule for maintenance?

Is the maintenance log for each piece of equipment kept on or

Yes
near the equipment?
4.3.EquipmentMaintenance&Cleaning-100%

Equipment Maintenance & Cleaning 100%

 Are written procedures established for the cleaning and
Yes
maintenance of equipment and utensils?

Are these procedures followed? Yes

Does a written procedure assign responsibility for the

Yes
cleaning and maintenance of equipment?

Has a written schedule been established and is it followed for

Yes
the maintenance and cleaning of equipment?

Has the cleaning procedure been properly validated? Yes

If appropriate, is the equipment sanitized using a procedure

Yes
written for this task?

Has a sufficiently detailed cleaning and maintenance

procedure been written for each different piece of equipment
Yes
to identify any necessary disassembly and reassembly
required to provide cleaning and maintenance?

Does the procedure specify the removal or obliteration of

production batch information from each piece of equipment Yes
during its cleaning?

Is equipment cleaned promptly after use? Yes

Is clean equipment clearly identified as "clean" with a

Yes
cleaning date shown on the equipment?

Is clean equipment adequately protected against

Yes
contamination prior to use?

Is equipment inspected immediately prior to use? Yes

Are written records maintained on equipment cleaning,

sanitizing, and maintenance on or near each piece of Yes
equipment?
4.4.MeasurementEquipmentCalibrationProgram-100%

Measurement Equipment Calibration 100%

Program

Does the facility have approved written procedures for

checking and calibration of each piece of measurement
equipment? (Verify procedure and log for each piece of Yes
equipment and note exceptions in notebook with cross
reference.)

Are records of calibration checks and inspections maintained

Yes
in a readily retrievable manner?
4.5.EquipmentQualificationProgram-100%
Equipment Qualification Program 100%

Verify that all pieces of equipment used in production,

packaging, and quality assurance are capable of producing Yes
valid results.

When computers are used to automate production or quality

Yes
testing, have the computer and software been validated?

Have on-site tests of successive production runs or tests been

Yes
used to qualify equipment?

Were tests repeated a sufficient number of times to ensure

Yes
reliable results?

Is each piece of equipment identified to its minimum and

maximum capacities and minimum and maximum operating Yes
speeds for valid results?

Have performance characteristics been identified for each

piece of equipment? (May be provided by the manufacturer, Yes
but must be verified under typical operations conditions.)

Have operating limits and tolerances for performance been

Yes
established from performance characteristics?
5.Material/ComponentControl-100%

Material/ Component Control 100%

5.1.Material/ComponentSpecificationandPurchasingControl-100%

Material/Component Specification and 100%

Purchasing Control

Although purchasing is not specifically addressed in the

current GMP regulation, incumbent upon user of components
Yes
and materials to ensure quality of product, material or
component.

Has each supplier/vendor of material or component been

inspected/audited for proper manufacturing controls?
Yes
(Review suppliers and audits and enter names, material
supplied, and date last audited in notebook.)
5.2.Material/ComponentReceipt,Inspection,Sampling,andLaboratoryTesting-100%

Material/Component Receipt, Inspection, 100%

Sampling, and Laboratory Testing

Does the facility have current written procedures for

acceptance/rejections of drug products, containers, closures, Yes
labeling and packaging materials?

Is each lot within each shipment of material or components

assigned a distinctive code so material or component can be Yes
traced through manufacturing and distribution?

Does inspection start with visual examination of each

shipping container for appropriate labeling, signs of damage, Yes
or contamination?

Is the number of representative samples taken from a

container or lot based on statistical criteria and experience Yes
with each type of material or component?

Is the sampling technique written and followed for each type

Yes
of sample collected?

Is the quantity of sample collected sufficient for analysis and

Yes
reserve in case retesting or verification is required?

Verify that the following steps are included in written

Yes
procedures unless more specific procedures are followed:

Containers are cleaned before samples are removed. Yes

Stratified samples are not composited for analysis. Yes

Containers from which samples have been taken are so

Yes
marked indicating date and approximate amount taken.

Each sample container is clearly identified by material or Yes

 component name, lot number, date sample taken, name of
person taking sample, and original container identification.

At least one test is conducted to confirm the identity of a raw

material (bulk chemical or pharmaceutical) when a Certificate Yes
of Analysis is provided by supplier and accepted by QA.

If a Certificate of Analysis is not accepted for a lot of material,

then additional testing is conducted by a written protocol to Yes
determine suitability for purpose.

Microbiological testing is conducted where appropriate. Yes

5.3.MaterialComponentStorageandHandling-100%

Material Component Storage and Handling 100%

Verify that materials and components are stored and handled

Yes
in a way that prevents contamination, mix-ups, and errors.

Are incoming material and components quarantined until

Yes
approved for use?

Are all materials handled in such a way to prevent

Yes
contamination?

Are all materials stored off the floor? Yes

Are materials spaced to allow for cleaning and inspection? Yes

Are labels for different products, strengths, dosage forms,

Yes
etc., stored separately with suitable identification?

Is label storage area limited to authorized personnel? Yes

Are rejected components, material, and containers

Yes
quarantined and clearly marked to prevent their use?
5.4.InventoryControlProgram-100%

Inventory Control Program 100%

Are inventory control procedures written? Yes

Does the program identify destruction dates for obsolete or

Yes
out-dated materials, components, and packaging materials?

Is stock rotated to ensure that the oldest approved product or

Yes
material is used first?

Is destruction of materials documented in a way that clearly

identifies the material destroyed and the date on which Yes
destruction took place?
5.5.Vendor(Supplier)ControlProgram-100%
Vendor (Supplier) Control Program 100%

Are vendors periodically inspected according to a written

Yes
procedure?

Is the procedure for confirming vendor test results written

Yes
and followed?
6.OperationalControl-100%

Operational Control 100%

6.1.Material/Component/LabelVerification,Storage,andHandling-100%

Material/Component/Label Verification, 100%

Storage, and Handling

Do written procedures identify storage time beyond which

components, containers, and closures must be reexamined Yes
before use?

Is release of retested material clearly identified for use? Yes

Are retesting information supplements originally obtained? Yes

Do written procedures identify steps in the dispensing of

Yes
material for production?

Do these procedures include (1) release by QC, (2)

Documentation of correct weight or measure, and (3) Proper Yes
identification of containers?

Does a second person observe

weighing/measuring/dispensing and verify accuracy with a Yes
second signature?

Is the addition of each component documented by the person

Yes
adding the material during manufacturing?

Does a second person observe each addition of material and

Yes
document verification with a second signature?

Does a written procedure specify who is authorized to issue

Yes
labels?

Does a written procedure specify how labels are issued, used,

reconciled with production, returned when unused, and the Yes
specific steps for evaluation of any discrepancies?

Do written procedures call for destruction of excess labeling

on which lot or control numbers have been stamped or Yes
imprinted?
6.2.Equipment/Line/AreaCleaning,Preparation,andClearance-100%

Equipment/Line/Area Cleaning, 100%

Preparation, and Clearance

Do written procedures detail how equipment is to be checked

immediately prior to use for cleanliness, removal of any labels Yes
and labeling from prior print operations?

Do written procedures detail any disconnection and

Yes
reassembly required to verify readiness for use?
6.3.OperationalProcessValidationandProductionChangeOrderControl-100%
 Operational Process Validation and 100%
Production Change Order Control

Have production procedures been validated? (Review selected

Yes
procedures for validation documentation. Adequate?)

Does the process control address all issues to ensure identity,

Yes
strength, quality, and purity of product?

Does the procedure include formulation that is written to

yield not less than 100% of established amount of active Yes
ingredients?

Are all weighing and measuring preformed by one qualified

Yes
person and observed by a second person?

Have records indicated preceding policy been followed by

Yes
presence of two signatures?

Are actual yields calculated at the conclusion of appropriate

Yes
phases of the operation and at the end of the process?

Are calculations performed by one person? Is there

Yes
independent verification by a second person?
6.4.In-ProcessInspection,Sampling,andLaboratoryControl-100%

In-Process Inspection, Sampling, and 100%

Laboratory Control

Are written procedures established to monitor output and

validate the performance of manufacturing procedures that
Yes
may cause variability in characteristics of in-process materials
and finished drug products?

Are in-process materials tested at appropriate phases for

identity, strength, quality, purity and are they approved or Yes
rejected by Quality Control?

Are there laboratory controls including sampling and testing

procedures to assure conformance of components,
Yes
containers, closures, in- process materials, and finished
product specifications?
6.5.Reprocessing/DispositionofMaterials-100%

Reprocessing/Disposition of Materials 100%

Do written procedures identify steps for reprocessing

Yes
batches?

Are quality control review and approval required for any and
Yes
all reprocessing of material?
Does testing confirm that reprocessed batches conform to
Yes
established specification?

Does a written procedure outline steps required to reprocess

returned drug products (if it can be determined that such
Yes
products have not been subjected to improper storage
conditions?)

Does Quality Control review such reprocessed returned goods

and test such material for conformance to specifications Yes
before releasing such material for resale?
7.FinishedProductControl-100%

Finished Product Control 100%

7.1.FinishedProductVerification,Storage,andHandling-100%

Finished Product Verification, Storage, and 100%

Handling

Do write procedures indicate how and who verifies that

correct containers and packages are used for finished product Yes
during the finishing operation?

In addition, do written procedures require that representative

sample of units be visually examined upon completion of Yes
packaging to verify correct labeling?

Are expiration dates stamped or imprinted on labels? Yes

Are expiration dates related to any storage conditions stated

Yes
on the label?

Are all finished products held in quarantine until QC has

completed its testing and releases product on a batch to Yes
batch basis for sale?

Is finished product stored under appropriate conditions of

Yes
temperature, humidity, light, etc.
7.2.FinishedProductInspection,Sampling,Testing,andReleaseforDistribution-100%

Finished Product Inspection, Sampling, 100%

Testing, and Release for Distribution

Has the formulation for each product been tested for stability
based on a written protocol? (Containers must duplicate those Yes
used in final product packaging.)

Are written sampling and testing procedures and acceptance

criteria available for each product to ensure conformance to Yes
finished product specifications?

Is a quantity of samples equal to at least twice the quantity

needed for finished product release testing maintained as a Yes
reserve sample?

Are sterility and pyrogen testing performed as required? Yes

Are specific tests for foreign particles or abrasives included

Yes
for any ophthalmic ointments?

Do controlled release or sustained release products include

Yes
tests to determine conformance to release time specification?
7.3.DistributionControls-100%

Distribution Controls 100%

 Does a written procedure manage stocks to ensure that oldest
Yes
approved product is sold first?

Are deviations to the policy above documented? Yes

Does a written procedure identify the steps required if a

Yes
product recall is necessary?

Is the recall policy current and adequate? Yes

7.4.MarketingControls-100%

Marketing Controls 100%

The current regulation does not address marketing controls

per se except that all finished products must meet their Yes
specifications.
7.5.ComplaintHandlingandCustomerSatisfactionProgram-100%

Complaint Handling and Customer 100%

Satisfaction Program

Are complaints, whether received in oral or written form,

Yes
documented in writing and retained in a designated file?

Are complaints reviewed on a timely basis by the Quality

Yes
Control Unit?

Is the action taken in response to each complaint

Yes
documented?

Are decisions not to investigate a complaint also documented

Yes
and the name of the responsible person documented?

Are complaint investigations documented and do they include

investigation steps, findings, and follow-up steps, if required? Yes
Are dates included for each entry?
8.Completion

Completion

Final Notes

Create and formally document the establishment of a dedicated QA team ASAP.

Sign off

Herman Lucio
28 Jun 2023 10:17 PST