GMP Audit Cosmetics Products: Example Report

GMP Audit
Cosmetics Products
* Example Report *

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Email
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GMP
GMP for for Cosmetics
Cosmetics Rev
Rev.
SUMMARYPHOTO
FACTORY 11
Supplier Name Audit Date Report No.

XXXXXXXXXX
XXXXXXXXXX XXXXXXXXXX
XXXXXXXXXX XXXXXXXX
XXXXXXXX
SUPPLIER INFORMATION CLIENT INFORMATION

NAME : XXXXXXXXXX NAME : XXXXXXXXXXXXXXX
ADRESS : XXXXXXXXXX ADRESS : XXXXXXXXXXXXXXX

XXXXXXXXXX XXXXXXXXXXXXXXX
CITY : XXXXXXXXXX CITY : XXXXXXXXXXXXXXX
COUNTRY : XXXXXXXXXX COUNTRY : XXXXXXXXXXXXXXX
PHONE : XXXXXXXXXX PHONE : XXXXXXXXXXXXXXX
FAX : XXXXXXXXXX FAX : XXXXXXXXXXXXXXX
PARTICIPATING PERSONNEL
Mr./Mrs. XXXXXXXXXX Title: XXXXXXXXXXX Email: XXXXXXXXXXXXXXXX

Mr./Mrs. XXXXXXXXXX
34. SOPs on site Title: XXXXXXXXXXX Email:
35. Identification XXXXXXXXXXXXXXXX
of semi-finish on site
CONTACT PERSONNEL
Mr./Mrs. XXXXXXXXXXX Title: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Mr./Mrs. XXXXXXXXXXX Title: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
AUDIT RESULTS
Complies Needs Improvement Does Not Comply
Personnel
Documentation Training 100.0% 0.0% 0.0%
Personnel Hygiene and Health
Change Control 100.0% 0.0% 0.0%
Premises
Complaints
36. Record and Recalls card
ofPest
process 100.0% 37. Record
0.0% of in-process
0.0% inspection.
Control
Non-conforming products 100.0% 0.0% 0.0%
Equipment
SubcontractingCalibration
Manufacturing #DIV/0! #DIV/0! #DIV/0!
Waste Control
Maintenance 100.0% 0.0% 0.0%
RawQuality Control
Materials Laboratory
and Packaging 100.0% 0.0% 0.0%
Finished Products
Identification and Status 100.0% 0.0% 0.0%
Packing Operations Storage 100.0% 0.0% 0.0%
Production
Bulk Product Storage 100.0% 0.0% 0.0%
Bulk Product Storage
Production 100.00% 0.00% 0.00%
Packing Operations
Storage 100.00% 0.00% 0.00%
Finished Products
Identification and Status 100.00% 0.00% 0.00%
Quality Control Laboratory
Raw Materials and Packaging Materials 75.00% 25.00% 0.00%
Waste Control
Maintenance
Subcontracting Manufacturing 100.00% 0.00% 0.00%
Calibration
Non-conforming products 100.00% 0.00% 0.00%
Equipment
Complaints and Recalls 100.00% 0.00% 0.00%
37. Photo of production 38. Data analysis of defectives from production
Pest Control
Change Control 100.00% 0.00% 0.00%
Premises Documentation 88.89% 11.11% 0.00%
Personnel Hygiene and Health
0% 10% 20% 30% 100.00%
40% 0.00% 60%
50% 0.00%
70% 80% 90% 100%
Complies Needs Improvement Does Not Comply
Training 75.00% 25.00% 0.00%
Personnel 100.00% 0.00% 0.00%
JUDGEMENT & RECOMMENDATIONS
GMP, ISO 22716:2009 By: Pablo C. Approved by: Jean C. 6/7

GMP
GMP for for Cosmetics
Cosmetics Rev
Rev.
SUMMARYPHOTO
FACTORY 11

XXXXXXXXXX
XXXXXXXXXX XXXXXXXX
XXXXXXXX
Passed,SUPPLIER
the QMS is effective, you could consider this supplier a reliable business partner.
INFORMATION CLIENT INFORMATION
Passed, the QMS is acceptable with minor NCFs (see Audit Report), you could consider this
supplier a reliable business partner, but continue to require improvement to reduce risk.
On-hold, the QMS presents a few major NCFs (see Audit Report), you could request them to
provide a CAPA before engaging in any business with them.
Failed, the QMS presents major NCFs (see Audit Report) that could impact upon
your business. The better solution would be to source another supplier.
34. SOPs on site 35. Identification of semi-finish on site
36. Record of process card 37. Record of in-process inspection.
GMP, ISO 22716:2009 By: Pablo C. Approved by: Jean C. 6/7

GMP for Cosmetics
GMP for Cosmetics Rev.
REPORT 0
FACTORY PHOTO
XXXXXXXXXX
Supplier Name XXXXXXXXXX XXXXXXXX
Audit Date Repo
Scope of Audit: XXXXXXXXXX XXXXXXXXXX XXXX
The intent of conducting a Quality System audit based on ISO 22716:2007 requirements is to provide the
client with information useful for making an initial assessment about business viability, and reducing their
sourcing risks.
Summary/Recommendation:
The audited factory XXXXXXXXXXXXXXXXXXXX was founded in 1992, it specializes in the production of
cosmetics products such as Cosmetic Pencils, Powder Series, Color Cosmetics, Cosmetic Kits, Newness
...etc.
The company is located in XXXXX city which is considered the biggest small commodity center in the
world. The factory covers an area of 30000 square meters and has around 200 employees working full
time. The factory has 4 mains buildings, one for offices, a workshop of 4 floors for production under
100,000 class level air purification plant,and one building for dormotories.
The main market covers US, Europe, Russia, Japan, South America, Africa, etc, where they have been
selling around 1000 various professional products.
The factory has34.been certified

SOPs to ISO 22716: 2009 for cosmetic products by
on site SGS
35. since 17th of
Identification Sep, 2016
semi-finish on site
which will expire on Sep 4th 2018. The scope of the certification includes Manufacturing of cosmetic
products. The certificate number is CN12/20287. Meanwhile, the factory also obtained a compliance
certificate for regional requirements of US FDA (CN/21333), as well as an EU compliance certificate.
Evidence of compliance with those standards are available on-site.
However, the factory must improvement enhance employee skill / training with effective evaluation
system, others details of opportunities of improvement are listed here below:
Strengths:
1) Certified to ISO 22716: 2007, USA FDA and EU.
2) Well maintained cleanroom of 100,000 class level.
3) Production manager with more than 12 years experience in the cosmetics industry.
4) Large show room, and enough space in the production area to enlarge production capacity.
Opportunities for Improvement:

1) The factory must plan the type of evaluation to be conducted after training, and must keep a record.
2) The factory should define

36. Record an adequate
of process card intensity of light for specific workshops or areas.
37. Record The factoryinspection.
of in-process
must purchase a device that will the periodic conducting of inspections of the intensity of the
lighting system
3) An authory must review and approve the list of selected and approved suppliers.
GMP
GMP forfor Cosmetics
Cosmetics Rev
Rev
CHECKLIST 1
FACTORY PHOTO 1
XXXXXXXXXX XXXXXXXXXX ITS00058090HM
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
3.0 Personnel
1) Yes, there is an organization chart

1) Photograph the org. chart 2) Quality Manual MX/GMPC-QM-001,
Is there an organizational chart
Name the Quality Manager Rev A, Page 6/67.
3.0.1 available? Is the Quality Department C
3) How many QC in Quality Dept.? 2) The Quality Manager is Mr. Tong, and
independent?
4) Does he report directly to GM? he reports to GM directly.
3) The Quality Depart has 10 peoples.
Yes, the Quality Manual MX/GMPC-QM-

Is top management committed to 001 contains commitment letter signed
1) Commitment letter signed by the
3.0.2 implement Good Manufacturing in 2015-06-01 to comply to C
top management.
Practices? requirements of ISO9001:2008,
34. SOPs on site ISO22716-2007.
35. Identification of semi-finish on site
Yes, the Quality Manual MX/GMPC-QM-

Are department Managers committed 001 contains commitment letter signed
1) Commitment letter signed by each
3.0.3 to implement Good Manufacturing in 2015-06-01 to comply to C
department Manager
Practices? requirements of ISO9001:2008,
ISO22716-2007.
Yes, job description and responsibilities

Are their job responsibilities defined
1) Review Job Description of Quality of each Department are documented in
3.0.4 and communicated to related C
Department. the file MX-2-XZ-001, published since
personnel?
2015-6-01.
Yes, the Quality Manager knows his

Is proper information available to 1) Interview Quality Manager if he
responsibilities. Job Description is
3.0.5 employees to comply with know his JD. C
documented and posted on-site (See
responsibilities assigned? 2) Check if the JD is posted.
photo 10).
3.4 36. Record of process card Training 37. Record of in-process inspection.
Yes, there is a procedure for employee

1) Write procedure (Doc, Rev) training documented in the Quality
Is there any procedure for
3.4.1.1 2) Describe how training needs are Manual MX/GMPC-QM-001, Rev A, C
identification of training needs?
identified. Page 27/67. Chapter 4 describes how
training needs are identified.
1) Photograph training plan. Yes, there is a training program for 2017

Is an appropriate training program
3.4.1.2 2) Number of subjects with 29 trainings topics to be conduct in C
developed?
3) number of subjects done. 9 different days (See photo 3)

GMP
Cosmetics Rev
Rev
CHECKLIST 1
FACTORY PHOTO 1
Yes, record of the following training was

reviewed:
1) Requirement of GMPC, BRC
Are training courses appropriate to
1) Review and photograph training knowledge conducted in 2016-3-15, and
3.4.1.3 the jobs and responsibilities of C
need submitted by department recorded in the sheet. Q/MX306001
individuals?
(See photo 4). 2)
Requirement of EEC conducted in 2017-
06-19, and recorded.
Yes, new employees are trained about

Do newly recruited personnel receive 1) Note subject to newly hired. cleanness, personnel hygiene and
3.4.1.4 C
appropriate training? 2) Photograph training records health. Training records are available
(See photo 5)
There is a procedure for employee

training. MX/GMPC-QM-001, Rev A,
Is the type of evaluation
1) Review and photograph record of Chapter 2.7, page 27/67 requires
3.4.1.5 documented? Is knowledge evaluated I
evaluation. training evaluation to be conducted. But
during and/or after training?
the factory was unable to show any
records of such evaluation
3.5 Personnel Hygiene and Health
Yes, there is a hygiene programme

established as followed:
Is a hygiene programme established Water hygiene (MX-2-XZ-003.
1) Photograph hygiene program.
3.5.1.1 and adapted to the needs of the Employee hygiene (MX-2-XZ-004). C
2) Describe the hygiene frequency.
plant? Contamination control (MX-2-XZ-005).
Wash hand (MX-2-XZ-007)
Pest control (MX-2-XZ-010)
Yes, the program is followed, and

records are kept:
1) Record of employee hygiene (See
Is the program followed in every area 1) Photograph in production / photo 6). 2)
3.5.1.2 C
required? Are records posted. warehouse..etc.? Record of machine cleanness in sheet
Q/MX307019, for example of machine
Nb. MX.1013 (See photo 8).
3) Record of equipment (See photo 9)
1) Facilities for hand washing are

1) Photograph if any facilities for hand
provided (See photo 11).
washing?
Are personnel instructed to use hand 2) WIs that instruct employees to wash
3.5.1.3 2) Photograph if there is any Work C
washing facilities? hands are documented in WI MX-2-XZ-
Instruction posted on-site about how
007, and posted in the workplace (See
to wash hands.
photo 12).

GMP
Cosmetics Rev
Rev
CHECKLIST 1
FACTORY PHOTO 1
Are finished products which

are released, quarantined or rejected, Yes, the factory has different areas to
8.0.5 stored in their respective physical store finished products depending on C
locations or is a data system available the quality status.
which ensures segregation?
9 Quality Control Laboratory
Do the principles described for Yes, cleanliness requirements, env.

personnel, premises, equipment, control are the same. However, the lab
status of cleanliness, maintenance,
9.0.1 subcontracting and documentation center is not considered as a cleanroom C
identification, skill matrix…etc
also apply to the quality control since it is located off that premises, in
laboratory? another building.

Procedure MX-2-YW-004 indicates
Is the quality control practices for recall. Practice of recall
laboratory responsible for sampling, documented. For example, in 2016/7/23
9.0.2 Work Instruction C
controls and releases according to product of lot number 2016129
defined acceptance criteria? complaint received in 2016/7/21 at
18:00. Product Model 10M.
Does the quality control laboratory

use all test methods which are
Yes, necessary methods used for
9.0.3 necessary to confirm that the product Test methods, records C
testing.
complies with the acceptance
criteria?
Are the laboratory results

9.0.4 Test methods, records Yes, records of results are maintained. C
documented & reviewed?
Yes, traceability of test results are

Is there clear traceability of inspecton Review record, note lot number of
9.0.5 maintained, per lot number of incoming C
results? material tested, date, tester…etc
36. Record of process card 37. material.
Record of in-process inspection.
Are the samples of finished products

Sample retention place, period,
9.0.6 retained in an appropriate manner Yes, samples are maintained C
identification…etc
and in designated areas?
10 Waste Control
Are wastes disposed of in a timely Procedure for waste control, Yes, there is a program for waste
10.0.1 C
and sanitary manner? document number disposal.
Are the types of waste for the given Yes, there is a waste management
production processes that could affect List of type of waste from production, procedure, MX-2-PG-026, in which
10.0.2 C
the quality of the finished products and control method arrangements for waste control are
defined? defined.

GMP
Cosmetics Rev
Rev
CHECKLIST 1
FACTORY PHOTO 1
Are the individual measures Yes, each workshop has a specific box
of collection, transportation, storage for collection of waste. And waste is
10.0.3 C
and disposal of wastes adequately collected every day and taken off the
documented? premises.
Are the containers of waste properly

Yes, containers of wastes are available
10.0.4 identified (possibly with additional Photograph containers of waste C
at each workshop.
information)?
11 Subcontracting Manufacturing
Are subcontracting / services and

The factory has no service to
11.0.1 contract manufacturing defined in a 1) Procedure for sub-contracting. N/A
subcontract, Not applicable
written contract?
34. SOPs
Are checks on site
and audits by the contract 35. Identification of semi-finish on site
The factory has no service to
11.0.2 giver at the contract acceptor 1) record of last check/audit N/A
subcontract, Not applicable
contractually fixed?
Does the contract acceptor

inform the contract giver of any The factory has no service to
11.0.3 Is this mentione din the contract? N/A
planned changes that may affect the subcontract, Not applicable
quality of the services or products?
Are the duties and responsibilities

(delimitation of obligations / The factory has no service to
11.0.4 Review the contract N/A
responsibilities, “matrix”) of the two subcontract, Not applicable
parties defined in the contract?
12 Non-conforming products
Are measures available which

regulate the approach in the event of Procedure to solve NCF/ deviation in There is a procedure to control NCFs
12.0.1 C
non-conformities from specified product or process MX-2-PG-057, Rev A/0
requirements?

Yes, information is available for
potential root cause investigation and
respective corrective action.
Are sufficient data available Products are inspected 100% before
12.0.2 for the decision about a possible Log of NCF / deviation packaging, and all NCF parts are C
correction? identified and then recorded on a sheet
(See photo 37). Those data are
expressed in a graphical manner to
display the deviation (See photo 38).
Are the corrective measures

Yes, reviewed 3 cases of NCFs found at
implemented in such a way that Record of corrective action in few
12.0.3 the final inspection. For PO 2016425, C
recurrence of non-conforming deviations.
2016458 and 16228 (See photo 39)
products is avoided?
13 Complaints and Recalls

GMP
Cosmetics Rev
Rev
CHECKLIST 1
FACTORY PHOTO 1
Yes, the procedure is MX-2-YW-005,

Are all complaints that fall within the
Rev A/0.
scope of these guidelines and are
Reviewed 3 cases of complaints. For
13.0.1 communicated to the plant reviewed, 1) Procedure for complaint. C
example PO 2016153, MX2016435,
investigated and followed up, as
MX2016378, MX2016349 (See photo
appropriate?
40)
Are appropriate steps taken

Yes, there is a procedure for the recall
in the event of a product recall
1) Procedure of recall MX-2-YW-003, Rev A/0, and procedure
13.0.2 decision in order to complete the C
2) Record of recall and actions. MX-2-YW-004 applies to the practice of
recall within the scope of these GMP
the recall procedure.
guidelines?
In the case of a product

Yes, respective corrective action is
recall34. SOPsare
decision, oncorresponding
site Record of corrective action for a 35.
recallIdentification of semi-finish on site
13.0.3 required in the procedure MX-2-YW- C
corrective and preventive measures decision.
003, in chapter 3.8, page 3/4
initiated?
Are complaints reviewed

periodically to check for trends or Yes, there is a prevision to review the
13.0.4 Pareto graphic for complaint. C
recurrence of a defect on a trends, and data is available.
precautionary basis?
Are product recall

13.0.5 operations initiated promptly and in a A recall has never occurred. N/A
timely manner?
Are recalled products stored

13.0.6 separately in a secure area while A recall has never occurred. N/A
awaiting a decision?
Procedure MX-2-YW-004 indicates the

practice for recalls. The recall of
36. Record of process card 37. Record
productsofis in-process
documented, inspection.
for example,
Is the product recall process on 2016/7/23 product with lot number
13.0.7 C
evaluated periodically? 2016129, complaint recall received on
2016/7/21 at 18:00. Product Model
10ML of logo Charlene, client Number
MX163.
14 Change Control
Has a process been defined for Yes, there is a procedure for change
changes (plants, material, process control MX-2-YW-001, Rev A/0. Change
14.0.1 Procedure to handle change C
etc.) which could affect the quality of often happens in raw materials, quality
the product? in the client PO…etc.

GMP
Cosmetics Rev
Rev
CHECKLIST 1
FACTORY PHOTO 1
Yes, it is planned that when a change

request comes from the client. They will
Are changes performed by a
14.0.2 review the request and inform the client C
defined authorised personnel?
about the approval to implement the
change.
Yes, in sheet MX306001-2017, for

Record of change (plants, material,
14.0.3 Are the changes documented? example of client MX020 for PO number C
process etc.)
2017192
15 Documentation
1) Yes, the organization has a Quality

Manual MX/GMPC-QM-001, published
Does the company have an adequate
since 2015, to meet requirements of
system of documentation established
ISO 9001:2008, ISO 22716:2007, FDA-
and implemented that is appropriate 1) Quality Manual
15.0.1 GMPC and EEC C
to its organisational structure and 2) List of applicable procedures
2) The factory established a list of
type of products, and does it maintain
applicable procedures to support the
such a system?
implementation of the commitment
outlined in the Quality Manual.
Does the documentation

system include all instructions, Yes, the documentation includes all
specifications, test protocols, reports, DMR files, operational procedures,
1) Review DMR files
15.0.2 methods and records appropriate to maintenance SOPs. All defined as per C
2) Procedure for control of DMR file.
the activities covered by the GMP GMP for cosmetic product
guidelines? (as hard copy paper or requirements.
electronic data processing record)
Do the defined documents describe

the corresponding operations to be Yes, there are SOPs for inspection in
36. Record of process card
carried
37. Record of in-process inspection.
files MX-2-PG-019 / 020 / 021 / 022 /
15.0.3 C
out, precautions to be taken and 023 / 024 / 025 / 026 / 027 / 028 / 029 /
measures to be applied with 030.
appropriate detail?
Are documents, where necessary, Yes, documents are updated when

Procedure for document
updated and is the reason for revision applicable, and distributed following
15.0.4 control/change. C
and number and / or reason for the requirements of the document control
Record of change.
revision and version number stated? procedure.
Does the duration of Yes, the retention of document / record

15.0.5 archiving correspond to the applicable following the requirement of ISO C
legislation and internal regulations? 22716:2007
Yes, documents are stored on paper,

Are the stored / saved documents (in
are legible, and they are stored at the
15.0.6 paper or electronic form) legible and C
quality department office with secured
secured?
access.

GMP for CosmeticsGMP for Cosmetics
Rev
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date
1. Factory Building 2. Cosmetic product in Showroom
34. SOPs on site 35. Identification of
3. Training program for year 2017 4. Record of training
5. Training record of new employee 6, 7. Machine cleaning
36. Record of process card 37. Record of in-pr

Rev
FACTORY PHOTO 1
FACTORY PHOTO

Rev
FACTORY PHOTO 1
FACTORY PHOTO
39. Record of CAP from internal NCFs 40. Record of CAP from external client's complaint
41. ISO 22716 : 2007 Certificate 42. Certificate of FDA conpliance.

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GMP Audit

Europe & Middle-East

Asia & Asia Pacific

Supplier Name Audit Date Report No.

SUPPLIER INFORMATION CLIENT INFORMATION

ADRESS : XXXXXXXXXX ADRESS : XXXXXXXXXXXXXXX

Mr./Mrs. XXXXXXXXXX Title: XXXXXXXXXXX Email: XXXXXXXXXXXXXXXX

Mr./Mrs. XXXXXXXXXXX Title: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

GMP, ISO 22716:2009 By: Pablo C. Approved by: Jean C. 6/7

Supplier Name Audit Date Report No.

34. SOPs on site 35. Identification of semi-finish on site

36. Record of process card 37. Record of in-process inspection.

37. Photo of production 38. Data analysis of defectives from production

GMP, ISO 22716:2009 By: Pablo C. Approved by: Jean C. 6/7

The factory has34.been certified

Opportunities for Improvement:

2) The factory should define

1) Yes, there is an organization chart

Yes, the Quality Manual MX/GMPC-QM-

Yes, the Quality Manual MX/GMPC-QM-

Yes, job description and responsibilities

Yes, the Quality Manager knows his

Yes, there is a procedure for employee

1) Photograph training plan. Yes, there is a training program for 2017

37. Photo of production 38. Data analysis of defectives from production

Yes, record of the following training was

Yes, new employees are trained about

There is a procedure for employee

3.5 Personnel Hygiene and Health

Yes, there is a hygiene programme

36. Record of process card 37. Record of in-process inspection.

Yes, the program is followed, and

1) Facilities for hand washing are

37. Photo of production 38. Data analysis of defectives from production

Are finished products which

9 Quality Control Laboratory

Do the principles described for Yes, cleanliness requirements, env.

34. SOPs on site 35. Identification of semi-finish on site

Does the quality control laboratory

Are the laboratory results

Yes, traceability of test results are

Are the samples of finished products

37. Photo of production 38. Data analysis of defectives from production

Are the containers of waste properly

Are subcontracting / services and

Does the contract acceptor

Are the duties and responsibilities

Are measures available which

36. Record of process card 37. Record of in-process inspection.

Are the corrective measures

13 Complaints and Recalls

37. Photo of production 38. Data analysis of defectives from production

Yes, the procedure is MX-2-YW-005,

Are appropriate steps taken

In the case of a product

Are complaints reviewed

Are product recall

Are recalled products stored

Procedure MX-2-YW-004 indicates the

37. Photo of production 38. Data analysis of defectives from production

Yes, it is planned that when a change

Yes, in sheet MX306001-2017, for

1) Yes, the organization has a Quality