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• Ensure work environment is clean and tidy (5S).
• No dust on top of machine, racks, window ledge, etc.
• No pest.
• Ensure uniform are clean.
• All materials (raw material, component, WIP, finished goods, etc) properly segregated and labelled Designated stations (WIP, Quarantine, Reject, etc) properly labelled.
• Remove all unauthorised instruction or notes from wall or machines DO WHAT
• YOU SAY – Ensure Production operates as per written procedure SAY WHAT
• YOU DO – All records to be completed as required in procedure and meeting
• GMP requirements. Review records to ensure complete, no blanks, no over-writing, pencil marks, traces of pencil mark, correct info, correct date, etc.
• Identify your subject matter expert

What to check and confirm during an audit:

•There must be an escort accompanying the auditor at all time.
•Auditee cannot meet the auditor without the presence of escort
•Key personnel to be on standby and readily available.
•Auditor visit to Production area to be smooth and quick.
•REVIEW all data/documents before submitting to the auditor (Review team – correct revision, complete, any blanks, pencil mark, correct date, etc).
•Photography is not to be allowed.Don’t be fool by friendliness of auditor

• If a required SOP is not available or needs update, plan for remedial action before auditor close the audit
• This is not a show-off
• Show you are in control, talk with confidence

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To Whom It May Concern,

Product Number/Code Description

XYZ Sdn Bhd

The above products from our plant has been produced according to the GMP requirement, meeting the Quality System requirement of ISO 9001: 2008. These products have also passed requirements as per testing conducted per agreements.

They have been accepted at all stages of production through Incoming, Production, Inspection and Packaging. They have passed all Visual, Physical and Functional quality testing as stated in our Quality System.

______ ______________________________
Name Date
Title/Position

Hope that this simple example on Certificate of conformance template for ISO 9001 System helps you.For appreciation you may use this article/share this elsewhere as long as you provide links to this article.You may also interested on iso 9001:2008 free download and download free internal audit checklist template example

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1.0 Purpose
To outline training requirements for staff in the respective laboratory.

2.0 Scope
Training for Laboratory personnel.

3.0 Departments Affected
3.1 QA- Laboratory
3.2 Technical Laboratory
*Department Responsible – Respective Department Head

4.0 Procedure
4.1 The immediate supervisor shall :-
4.1.1 Brief all laboratory personnel on his/her position in the organization.

4.1.2 Explain their job function and responsibility.

4.1.3 Brief on relevant information concerning product knowledge.

4.1.4 Brief on the laboratory rules and safety requirements.

4.1.5 Record all training carried out in the staff ‘Job Training Record’.

4.2 Responsibilities and training on various test methods shall be conducted as per the respective
documents.
4.2.1 Microbiology Laboratory
4.2.1.1 Basics of Quality Control in Microbiology lab e.g, instruction to follow when preparing media/reagents, autoclaving/sterilizing, quality control of media, storage of media.

4.2.1.2 Aseptic technique.

4.2.1.3 Routine Microbiological testing, which is divided into several categories :-
A. Bioburden analysis, e.g, on finished goods, assemble materials and unit
packaging materials.

B. Environmental control of Cleanroom
- Microbial contamination
- Particulate contamination
- Cleanliness of Workbench
- Personal hygiene

C. Microbiological control of water and alcohol and liquid hand soap.

4.2.1.4 Use of equipment – microscope, laminar flow cabinet, autoclave, etc.

4.2.1.5 Procedure for collecting samples and arrangement for outside laboratory testing inclusive on generation of lab test requisition, Purchase Requisition and Invoice.

4.2.1.6 Recording of test result, report writing and filing.

4.2.2 Technical Laboratory
Lab testers shall be trained on :-
4.2.2.1 Introduction to materials in the production area that shall be subjected to testing by Technical Laboratory.

4.2.2.2 Sampling procedure and the necessary laboratory techniques applicable to their work, e.g.
- Titrimetric analysis.
- Preparation of solution/chemicals/buffers.
- Use of specific equipments for testing, e.g, (viscometer, pH meter, MST machine).
- Handling laboratory apparatus.

4.2.2.3 Checking/Testing of compounding and on-line materials
- Latex compound
- Coagulant
- Methcell
- Gum
- Slurry
- Dispersion/Solution

4.2.2.4 Record all testing results in appropriate log books or forms.

4.2.2.5 Monitor all parameters against specification and recommend for adjustment whenever necessary.

4.2.2.6 Checking of particle size and Brownian movement of prepared dispersion/chemicals.

4.2.2.7 Checking moisture content of catheters.

4.2.3 QA Incoming Laboratory
QA Inspectors will be briefed or trained on :-
4.2.3.1 Materials that are subjected to QA approval for use.

4.2.3.2 Usage of Sampling Plans.

4.2.3.3 Use of laboratory equipment, e.g, vernier caliper, dial gauge, ruler, etc.

4.2.3.4 Use of Raw Material Specification and Laboratory Test Reports.

4.2.3.5 Procedure for checking of incoming materials.

4.2.3.6 Preparation and writing reports.

4.2.4 Soak Test
4.2.4.1 Products that are subjected to tests.

4.2.4.2 Usage of Sampling Plans and procedures.

4.2.4.3 Test methods as per the following :-
- Reverse Flow Test
- Irrigation Flow Test
- Rupture Test
- Deflation Reliability
- Drainage eye occlusion and balloon leakage test

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Handling
1. Materials and products are suitably handled to prevent damage, deterioration, mix or contamination.
2. Procedures ensure materials and products are properly controlled in terms of issue, receipt and storage life requirements, as applicable.
3. Returned goods have systems set up for handling and appropriate disposition.

Storage
4. Products and materials are stored in such a way as to prevent contamination, damage, deterioration and allow stock rotation on a first in, first out basis.
5. Materials are stored off the floor on pallets, racks, shelves or containers. All storage equipment is maintained in a state of good repair to avoid damage to containers, contamination or damage to materials.
6. Systems are established for control of product/material with a limited shelf life or requiring special storage conditions. Special storage conditions are controlled and recorded.

Packaging
7. Product packaging is designed to prevent damage or deterioration and to maintain sterility for sterile products during storage and delivery to the customer.
8. Damaged cartons of sterile products are examined for breach of sterility barrier.

Labelling
9. Procedure is established to ensure that adequate controls exist to prevent labeling errors or mix-ups.
10. Labels are not released for use until a designated individual has examined the labeling for accuracy.
11. The release, including the date, name and signature of the individuals performing the label review is documented.
12. Labels are stored and maintained in a manner that provides proper identification and is designed to prevent mix-ups.
13. Access to labels is restricted to authorized personnel.

Delivery/Distribution
14. Established procedures define acceptable methods of product delivery. Product is shipped per contractual requirements where specified.
15. Only released products are distributed to customers. Records are maintained on original customer (consignee) name, address, product identification, quantity shipped and date of shipment.
16. Procedures are in place to ensure that products which have expired or deteriorated beyond acceptable use are not shipped.

Servicing and Installation
There are no documented procedures for servicing and installation as they are not applicable to company products.

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The Management Representative will establish an agenda for the review. This agenda will include at a minimum:
• Review and acceptance of previous meeting minutes
• Items elevated from lower level management reviews
• Status review of previous action items
• Quality Trends and metrics including:

• Complaint Trends
• CAPA Data
• All late CAPAs
  o All CAPAs that have received more than one
  extension
  o All CAPAs open longer than 90 days
  o Closure plans for all outstanding CAPAs
•  Audit result trends
  o All internal and external audit observations
  that have been open or issued since the last
  Management Review
• Product non-conformance trends
•  Process Performance
  • Regulatory trends (notified body observations, 483’s,
  warning letters, etc.)
  • Customer Feedback
  o Survey Results as applicable
  • Changes that could affect the quality management system

• Field corrective actions and recalls
• Impact of regulatory requirement changes on the Quality
System
• Other items defined by management at their discretion
• Recommendations for Improvement
The review output must include any decisions and actions
related to:
• Recommendations for specific actions designed to assure
the continued state of compliance with the Quality System.
• Resource needs are met.
• Improvement of product related to customer requirements.
• The attendance of the review by appropriate top
management with executive responsibility.
• Elevates as appropriate to the next level up, issues that
cannot or are not being addressed at a lower level, and
significant product or Quality System issues.

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Corrective Action
Steps that are taken to remove the causes of an existing
nonconformity or to make quality improvements. Corrective
actions address actual problems.
Correction
Repair, Rework, or adjustment and relates to the elimination of
an existing nonconformity. Also referred to as a “Remedial
Action”.
Evidence
Supporting materials used to prove or disprove something.
Investigation A systematic, minute, and thorough attempt to ascertain the
facts about something Complex or hidden.
Investigation Objective A statement of the desired outcome(s) of the corrective or
preventive action.
Investigation Strategy A written set of specific instruction for investigating and
determining the contributing and root causes of the problem.
Preventive Action
Steps that are taken to remove the causes of potential
nonconformities or to make quality improvements. Preventive
actions address potential problems, ones that haven’t yet
occurred.
Risk Analysis A systematic use of available information to determine the
frequency, detection and severity of their likely consequences.
Corrective and Preventive Action
Root Cause The most fundamental reason for the failure or inefficiency of a
process. The real cause or origin of a problem. The ultimate
source of an effect.
Root Cause Analysis
A technique used to identify the conditions that initiate the
occurrence of an undesired activity or state.

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Responsibility
Group management is responsible for establishing the requirements of this process. Site management is responsible for developing and implementing corrective and preventive actions.
Site quality management is responsible for ensuring that procedures are developed for corrective action and preventive action. The CAPA owner is responsible for ensuring all aspects
of this procedure are present in the CAPA file as completed.

Written procedures shall be in place, which govern all activities related to corrective actions. Information for determining
whether or not to initiate a corrective action may come from various sources.
Trend analysis data from quality records is reviewed on a regular basis for the purpose of evaluating effectiveness of
corrective and preventive actions, which have been taken. Documentation of failure investigations and corrective actions
are considered proprietary and confidential and are identified as
such. All employees have authority and responsibility to notify immediate supervisor of any problems they identify. The
supervisor in conjunction with Management will determine what corrective or preventive action must be taken and will document as appropriate

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Testing Overview
1. Stability testing is required for products manufactured and distributed by Company, which are intended to be sterile or non-sterile for single-use or reusable, prior to distribution. The stability requirements shall be defined by Product Functionality and Package Robustness.
2. Additionally, various product changes may occur to manufactured products over their lifecycle. These changes may or may not affect the functionality of a product and the products package robustness. Product, material, process and package changes will need to be reviewed by a cross-functional team. The cross-functional team will determine each specific change on a case-by-case basis to properly assess the change and any possible effects the change may have on the product’s ability to fully perform its intended function for its defined shelf life.

Tests Requirements
1. Completion of Testing:
Natural aging, time point, and functional testing must be completed within six weeks after the completion date of the stability test time point, unless stated otherwise in the test protocol provide by the engineer.

2. Product Functionality:
Product functional evaluation is specific and will be defined by each individual product. Individual tests will be conducted in accordance with formal test procedures and acceptance criteria will be established from the product’s Design Input Product Performance Specifications. The product functionality is expected to meet or exceed the acceptance criteria for the life of the product.

3. Package Robustness:
Package robustness will be evaluated and used to demonstrate package appropriateness by the combined review of the package’s seal strength and package integrity. Package robustness is necessary to protect the functionality of the product and maintain the sterility of the product. Package robustness is expected to meet or exceed the acceptance criteria for the life of the product.

Note: The following test methods outline the more common test methods available to perform package seal strength and integrity testing. Alternative methods to assess package seal strength and integrity testing can be considered and the engineer shall determine the best method for package robustness evaluation.

Note: Package testing can be carried out on final packages with or without including the medical device; it should be noted that the presence of a medical device can stress the package and cause changes in performance. If package testing is conducted without including the medical device, a rationale for no product shall be documented.

a. Seal Strength:
Package seal strength will be evaluated as a means to illustrate that the package sealing process is in control and within allowable seal strengths. The seal strength acceptance criteria will be established from the appropriate design specifications. Seal Strength testing is done according to the guidelines found in ISO-11607-1.

b. Package Integrity:
Package integrity evaluates the hermetic package environment by testing the package’s internal capacity. Package integrity is performed by searching for a breach of the package shell that may allow possible undesired microbial penetration resulting in a non-sterile package environment. The package integrity acceptance criteria will be established from the appropriate design specifications. Methods of evaluating package integrity are done in accordance with ISO-11607-1.

c. Visual Assessment:
Packaging robustness is not only a characterization of the package physical strength, but also its visual appearance and acceptance to the end user. The ability of the package to age and pass physical testing, but is perceived as visually distasteful to the end user, is not acceptable. Therefore, in addition to physical package testing the following visual evaluation based on the design specifications is required at each time point:
• Aesthetics
• Adhesion
• Peel-ability

Note: It is intended that historical data and supporting rationale are acceptable for use in the fulfillment of the requirements and verification of this Procedure.

Process
1. A protocol outlining the test plan shall be written and approved by a cross-functional team. The cross functional team and approvers shall be based upon each individual facility’s local procedures.

2. The stability protocol at minimum, must contain the desired expiration time points, test criteria and the accompanying test procedure (or reference documentation), acceptance criteria and sample size.

3. The sample size shall be determined using Statistical Techniques procedure

4. A copy of the approved protocol, test procedures, product samples and test request are to be delivered to the individual(s) responsible for testing, and completion of the test process.

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