ip-02-1001 hazard analysis and determination of critical control points (issue 04)

7/30/2019 IP-02-1001 Hazard Analysis and Determination of Critical Control Points (Issue 04)

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Doc # IP - 02 - 1001 Issue # 04 Page 1 of 18

STANDARD OPERATING PROCEDURE

TITLE: HAZARD ANALYSIS AND DETERMINATION OF

CRITICAL CONTROL POINTS

ASSIGNEE NAME TITLE SIGN./DATE

PREPARED BY Ibrahim abd elgaber QA OFFICER

REVIEWED BY Ibrahim abd elgaber QA SUPERVISOR

APPROVED BY AHMED SALAH QA MANAGER

HISTORY OF CHANGE

ISSUE #ISSUE

DATEPAGE # SUMMARY OF CHANGE

From Issue 001 To

Issue 00223/10/2005

23,4,5

13

Change in objective

Change in 4.4.1. , 4.5.2. , 4.7.1. , 4.8.1, 5.2.

Add attachment 5.5. , 5.6.

ISSUE DATE: //. EFFECTIVE DATE: //. REVISION DATE: //.


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1. OBJECTIVE:

1.1. To provide a drugs safety management system, aims to prevent known hazards and to

reduce the risks that they will occur at specific points in the manufacturing chain.

2. SCOPE:

2.1. All T3A products

3. RESPONSIBILITY:

3.1. Departments managers or designees: Nomination of the HACCP team members each

manager in his position, following up with the HACCP team leader the activity of

HACCP team members.

3.2. HACCP team leader or designee: Following up the activities of the HACCP team members.

3.3. HACCP team members: Carrying out the objectives and tasks that decided in the meetings

with in the due dates.

3.4. HACCP Co-ordinator or designee: Preparing the required documents, Issuing of the

controlled documents.

3.5. QA Manager or designee: review approval and system compliance.

4. PROCEDURE:

4.1. Assembling of HACCP team


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4.1.3.1.4.One member or more from R&D department.

4.1.3.1.5.One member or more from warehouse department.

4.1.3.2.Pharma HACCP team members:

4.1.3.2.1.One member or more from Pharma QC department.

4.1.3.2.2.Two member or more from Pharma production department.

4.1.3.2.3.One member or more from Maintenance department.4.1.3.2.4.One member or more from R&D department.

4.1.3.2.5.One member or more from warehouse department.

4.1.4.Team members shall be able to:

4.1.4.1.Conduct a hazard analysis.

4.1.4.2.Identify potential hazards.

4.1.4.3.Identify hazards which shall be controlled.

4.1.4.4.Recommend controls and critical limits.

4.1.4.5.Set the procedures for monitoring and verification.

4.1.4.6.Recommend appropriate corrective action where deviations occur.

4.1.4.7.Verify the HACCP plan.

4.1.5.In the first meeting ,the assembling of HACCP team approval form (attachment 5.1.) shall

filled by the team, signed by the Production manager, QC manager , Maintenance


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4.4.1.HACCP team construct a manufacturing flow diagram for each product or the products that

have same dosage form and the same sequence of preparation, the manufacturing flow

diagram shall contain the name of materials, material quantities, name of the process,

and each process parameter.

4.4.2.The team shall have a bird eye that covers all sources of hazards as:

4.4.2.1.Materials and ingredients.4.4.2.2.Physical characteristics and composition of the product.

4.4.2.3.Processing procedures.

4.4.2.4.Microbial limits, where applicable.

4.4.2.5.Premises.

4.4.2.6.Equipment.

4.4.2.7.Packaging.

4.4.2.8.Sanitation and hygiene.

4.4.2.9.Personnel and gowning.

4.4.2.10.Mix-up.

4.4.2.11.and others which determine by the HACCP team

4.4.3.The team uses the (attachment 5.4.) as a reference for constructing manufacturing flow

diagram


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4.6.3.During the on-site confirmation, the team shall take into consideration the sources of hazards

that not appear in the manufacturing flow chart.

4.7. Determination of critical control points

4.7.1.A CCP in the HACCP system shall be determined by using a decision-tree, (attachment 5.8

and 5.10) which facilitates a logical approach. The way that a decision-tree is used will

depend on the operation concerned. If a hazard has been identified at a step wherecontrol is necessary for safety, and no control measure exists at that step, or any other,

the product or process shall be modified at that step, or at an earlier or later stage, to

include such a control measure.

4.8. Establishing critical limits for each CCP

4.8.1.Critical limits must be specified and verified, if possible, for each critical control point. More

than one critical limit may sometimes be elaborated at a particular step. The criteria used

often include measurements of temperature, time, moisture level, pH, and sensory

parameters, such as visual appearance and texture. Critical limits shall be scientifically

based. The critical limits shall be identified in the HACCP Plan (Attachment 5.9.).

4.9. Establish a monitoring system for each CCP

4.9.1. Monitoring is the scheduled measurement or observation of a CCP relative to its critical

limits. Monitoring shall be recorded. The monitoring procedures used must be able to


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4.9.2.The critical control points and all another hazards write in the precautions and CCPs

announcement (attachment 5.5.) to be announced in the related production area.

4.10. Establishing corrective actions

4.10.1.Specific corrective actions shall be developed for each CCP in the HACCP system in order to

deal with deviations when they occur. These actions shall ensure that the CCP is brought

under control.4.10.2.Specific corrective actions shall be developed in advance for each CCP and included in the

HACCP plan. As a minimum, this plan shall specify what is to be done when a

deviation occurs, who is responsible for implementing the corrective actions, and that a

record will be kept and maintained of the actions taken.

4.11. Establishing verification procedures

4.11.1. Procedures shall be established for verification. Verification and auditing methods,

procedures and tests, including random sampling and analysis, can be used to determine

whether the HACCP system is working correctly. The frequency of verification shall be

sufficient to confirm the proper functioning of the HACCP system. Examples of

verification activities include:

4.11.1.1. Review of the HACCP system and its records.

4.11.1.2. Review of deviations and product dispositions.


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HACCP team shall modify the HACCP plan as necessary. Individuals doing verification

shall have appropriate technical expertise to perform this function. Where possible,

verification shall include actions to confirm the efficacy of all elements of the HACCP

plan.

4.12. Establish documentation and record keeping

4.12.1. Efficient and accurate documentation and record keeping are essential to the applicationof a HACCP system and shall be appropriate to the nature and size of the operation.

4.12.2. Examples of activities for which documentation is required include:

4.12.2.1. Hazard analysis

4.12.2.2. CCP determination.

4.12.2.3. HACCP plan.

4.12.2.4. Critical limit determination.

4.12.3. Examples of activities for which records are required include:

4.12.3.1. CCP monitoring activities.

4.12.3.2. Process steps.

4.12.3.3. Associated hazards.

4.12.3.4. Critical limits.

4.12.3.5. Verification procedures and schedule.


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5.7. On site conformation analysis5.8. Analysis of potential hazard against decision tree.

5.9. HACCP Plan.

5.10. HACCP decision-tree.


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5.1. Assembling Of HACCP Team Approval (Format Unique# 1804)

HACCP Team Activity area: .

Number of members: .

Date: ..........

Ser. # Member name DepartmentSignature

/ DatePosition

.......... . ...

.......... ...

.......... ...

.......... ...

.......... ...

.......... ...

.......... ...

.......... .. ...

.......... .. ...

.......... ...

.......... . ...


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5.2. HACCP team meeting minutes (Format Unique# 1812)

HACCP Team activity area: ...

Date: . /.. /..

Time: from : to ...: Attendance / agreement:

Decisions and responsibilities:

Name Responsible for Due date

................................. ............................................................................... ..........................

Ser.# Name Dept. Sign. Remark

........................................... .. .. .

........................................... .. .. .

........................................... .. .. .

........................................... .. .. .

........................................... .. .. . ........................................... .. .. .

........................................... .. .. .


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5.3. Products Identification (Format Unique# 1813 )

Products produced from Factory List no.: ..

Product Name Strength SectionManufacturing formula

Doc #

Processing instructions

Doc #

* The intended use and contraindications are listed in the product pamphlet

QC Manager Sign. /date: .....Production Manager Sign. /date: ..

QA Manager Sign. /date: .. Page ( ) of ( )

______________________________________________________________________________________________________

PREPARED BY: REVIEWED BY: .... APPROVED BY: ....


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5.4. Manufacture flow diagram (reference) (Format Unique# 1814)Product name: .

According to batch processing issue no.: .

Materials / quantities (1)

Materials / quantities (2)

Process (1)

Parameters

Process (2)

Parameters

Materials / quantities (3)Process (3)

Discussio

nDecision

Report NO

Yes


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5.5. Precautions and CCPs Announcement (Format Unique# 1815)Room #:

Equipment ID #: ..

Equipment major process:

The operator and IPC in this area shall be very careful with the following

Critical control points:

Process Step Product NameMonitoring

responsibilityCritical Limits

General precautions:

Precaution Remark


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5.6. Potential Hazards List (Format Unique# 1820)List no.: ..

Serial # Stage Process name Probable hazards Remarks


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5.7. On-Site Confirmation Analysis (Format Unique# 1821)

Stage Name: ..

Process Name:

Description:

Process Name Potential HazardHazard Type

Control PointsC M P


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5.8. Analysis Of Potential Hazard Against Decision Tree (Format Unique# 1822)

Process name Q1 Q2 Q3 Q4 Final Decision


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5.9. HACCP Plan (Format Unique# 1823)

Product name: . Plan no.: ..Activity area: ..

Process

Step

CCP

IdentificationType

Control

measureLimits

Corrective

action

/deviation

Monitoring

responsibility &

frequency

Used Format/

RecordsVerification

P = Physical hazard M = Microbiological hazard C = Chemical hazard

HACCP Team Approval (Name / date)

.. .. .. .. .. ..

______________________________________________________________________________________________________



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5.10. HACCP Decision-Tree(Format Unique# 1824)

______________________________________________________________________________________________________


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