Transcript
T3A INDUSTRIAL DOC # AP-05-1022
Issue # 01
Page 1 of 7
STANDARD OPERATING PROCEDURE PROCEDURE
TITLE: GOOD DOCUMENTATION PRACTICE ISSUE DATE: …/…/….
EFFECTIVE DATE: …/…/….
ASSIGNEE
NAME
REVISION DATE: …/…/….
TITLE
PREPARED BY
MOHAMMED ELASSADY
QA OFFICER
REVIEWED BY
MOHAMMED ELSAADY
QA SUPERVISOR
APPROVED BY
AHMED SALAH
QA MANAGER
SIGN./DATE
HISTORY OF CHANGE
ISSUE #
ISSUE DATE
PA G E #
SUMMARY OF CHANGE
T3A INDUSTRIAL DOC # AP-05-1022
Issue # 01
Page 2 of 7
1.OBJECTIVE: 1.1.This SOP describes the procedure for good documentation practice.
2.SCOPE: 2.1.
This SOP applicable for preparation of testing instructions, work instructions, analytical monograph, protocols, programs, plans, Specifications, site master file, Quality manual, Hazard analysis and critical control points [HACCP] management system manual, Environmental management system manual, and Organogram.
3.RESPONSIBILITIY: 3.1.Originating department initiator: Collecting the data, making a draft, organizing all raw data available; preparation, circulation of draft; make the corrections if needed and delivering it to Quality Assurance Officer. 3.2.Department manager or designee: Reviewing the master document before delivering it to quality assurance department. 3.3.Quality assurance officer or designee: Receiving of the master documents, reviewing, delivering to QA manager for approval, distribution and archiving. 3.4.QA Manager or designee: Reviewing, approval and system compliance.
4.PROCEDURE: 4.1.Preparation of testing instructions, work instructions, analytical monographs, protocols, programs and plans:
4.1.1.
Document approval procedure, re-Issue procedure and format requirements: Refer to the standard operating procedure "creation of standard operating procedure".
4.1.2.Digit “2” of document number denotes the type of document as follow:
4.1.3.
Instruction
I
Plan
L
Protocol
R
Program
G
Analytical monograph (methods of analysis)
M
Checklist
H
Subtitles that are common as follow:
_____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL DOC # AP-05-1022
Issue # 01
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1. OBJECTIVE:
Describes the task that this procedure covers and what is accomplished or produced when the procedures is successfully completed 2. SCOPE:
Describes the sites, areas, plants, and/or departments that this procedure applies to. 3. RESPONSIBILITY :
Describes the responsible persons for execution this procedures. 4. PROCEDURE:
Describes the steps of procedures and the person(s) involve in carrying them out 5. ATTACHMENT :
List all of items that are attached 4.2.
Preparation of specifications:
4.2.1.
Document approval procedure, re-Issue procedure and format requirements: Refer to the standard operating procedure "creation of standard operating procedure".
4.2.2.
Digit “2” of document number shall be "S".
4.2.3.
Subtitles are common as follow:
4.2.3.1.
For product specification: •
Product name
•
I.D. No.
•
Stage
•
Manufacturing formula #
•
Description
•
Sampling procedure
•
Qualitative and quantitative requirements and acceptance criteria
•
Storage conditions
•
Shelf life
•
Analytical monograph #
•
Qualitative and quantitative requirements and acceptance criteria
_____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL DOC # AP-05-1022 •
4.2.3.2.
4.2.3.3.
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Attachments (Certificate of analysis)
For starting material specification: •
Synonyms and brand names
•
Molecular Formula
•
Molecular weight
•
Material code
•
Sampling Plane
•
Sample Size
•
Handling Hazards
•
Analytical Monograph
•
Qualitative and quantitative requirements and acceptance criteria
•
Storage conditions and precautions
•
Supplier
•
Supplier Code
•
Manufacturer
•
Retest Date
•
Shelf life
•
Packaging unit
•
Package type
•
Supplier Quality Performance
•
References
•
Products in which the material is used
•
Attachments (Certificate of analysis)
For packaging material specification: •
Packaging material name
•
T3A identification Code
_____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL DOC # AP-05-1022
4.2.4.
•
Storage conditions
•
Approved Supplier
•
Sampling plan and procedure
•
Analytical monograph
•
Re-test date
•
Shelf life
•
Supplier Guarantee
•
Acceptance criteria
•
Attachment
o
Certificate of analysis
o
Approved design
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The certificate of analysis shall be as a table include test, acceptance criteria and reference and shall be signed by the QC analyst and QC manager.
4.3.Preparation of site master file:
4.3.1.
Site master file shall be succinct and as far as possible, not exceed thirty A4 pages.
4.3.2.
Simple plans, outline drawings or schematic layout shall be used instead of narrative.
4.3.3.
Site master file shall include general information about the firm, personnel organization& qualification, premises& equipments for manufacturing& services, documentation system, production procedures& capabilities, quality control system& activities, contract manufacturing& analysis, distribution, complaints& product recall procedures and Self inspection procedure.
4.3.4.
Site master file shall have an issue number and an effective date.
4.3.5.
Site master file shall be reviewed yearly.
4.4.Preparation of Quality manual:
4.4.1.
Quality manual shall include introductory pages, T3A in Brief, scope of activities, quality system requirement, management responsibility, resource management, product realization and measurement, analysis and improvement.
4.4.2.
Quality manual shall have an issue number and an effective date.
_____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL DOC # AP-05-1022 4.4.3.
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Quality manual shall be reviewed yearly.
4.5.Preparation of HACCP management system manual:
4.5.1.
HACCP management system manual shall include T3A HACCP policy, HACCP control, HACCP objectives and targets, HACCP management programs, organizational structure and responsibility, training & awareness and competence, communication & consultation,
HACCP
management
system
documentation,
document
control,
operational control, recall procedure, monitoring and measurements, corrective actions, records and record managements, HACCP system verification and record of revision. 4.5.2.
HACCP management system manual shall have an issue number and an effective date.
4.5.3.
HACCP management system manual shall be reviewed yearly.
4.6.Preparation of Environmental management system manual:
4.6.1.
Environmental management system manual shall include environmental& health& safety policy, environmental aspects& safety risk& hazard control, legal& other requirements, environmental& health& safety objectives & targets, environmental& health& safety management program, organizational structure& responsibility, training awareness& competence, communication& consultation, environmental& health& safety management system documentation, document control, operational control, emergency preparedness& response, monitoring& measurement, non conformance& corrective& preventive action, records, environmental& health& safety management system audit, management review and record of revisions.
4.6.2.
Environmental management system manual shall have an issue number and an effective date.
4.6.3.
Environmental management system manual shall be reviewed yearly.
4.7.
Preparation of organogram:
4.7.1.
Organogram shall have a unique document number, an issue number and an effective date.
4.7.2.
Digit “2” of document number shall be "O".
4.7.3.
Organogram shall be initiated for each department.
4.7.4.
Organogram shall be in a hierarchy form which describes the relation between the different positions in each department.
_____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
T3A INDUSTRIAL DOC # AP-05-1022 4.8.
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Factory Formats list: Refer to standard operating procedure "creation of standard
operating procedure".
5.
ATTACHMENT: NA
_____________________________________________________________________________________________________ PREPARED BY: ……………………… REVIEWED BY: …..…………………. APPROVED BY: ………………..…
