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Batch Production Record

BPR
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Quality
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Quality

Safety Stability
Efficacy
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Good Manufacturing Practice
(GMP)
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Regulations VS Guidelines
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Regulations VS Guidelines

‫ضوابط و الزامات‬
‫پیشنهاد دهنده‬
Regulation &
Recommendation
Requirements
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How to fulfil all GMP requirements?

EU, PIC/s GMP chapter 4, WHO GMP chapter 15:

Good documentation is an essential part of the QA system and key to

operation in compliance with GMP requirements.

‫مستندات و مستندسازی خوب یک بخش اساسی سیستم تضمین کیفیت و کلید‬

.‫ می باشد‬GMP ‫انطباق فرایند ها با الزامات‬
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So…….
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Records
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Thalidomide tragedy (1957 to 1961)-

- Sulfanilamide Disaster (1937)

( Taste of Raspberries, Taste of Death )
 1
Thalidomide tragedy-
- Sulfanilamide Disaster 5

( Taste of Raspberries, Taste of Death )

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Type of documents

 Standard Operating Procedure (SOPs(

 Batch Manufacturing/Production Record (BMR/BPR)
 Standard Testing Procedure (STPs)
 Specifications
 Records
 Labels
 Logbooks
 Master formula Record (MFRs)
 Other documents (SMF, Technical agreement Drawing, Flowcharts, Pictures, …)
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Type of documents


 What must be labeled? Containers, Equipment, Premises

 Label information : Clear, company format, indicating the status

 Label to be include:

• Name
 Labels • Potency or concentration
 • Date of manufacture
• Expiry date

• Date the closure is first opened
 • Storage condition
• Control number
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Batch Record
 ‫‪5‬‬

‫‪Batch Record‬‬

‫یک پارت از تولید یک محصول که‬

‫ویژگی ها و مقادیر مواد ابتدایی و‬ ‫ثبت صحیح پارامتر هایی‬
‫ویژگی های کیفی و کمی محصول‬ ‫که در ‪Quality‬‬
‫نهایی باهم همخوانی دارد و یژگی های‬ ‫محصول تاثیر دارد‬
‫‪.‬یکسان داشته باشد‪ ،‬تکرار پذیر باشد‬
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Batch Record
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Why
Batch Production Record
is important?
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‫?‪Why BPR‬‬
‫اعتبار شرکت‬

‫از الزامات‬
‫‪GMP‬‬
‫قابلیت‬
‫امکان‬ ‫امکان‬ ‫امکان بهبود‬
‫ردیابی‬
‫بررسی‬ ‫اصالح‬
 5

Instructions

Batch Record

Record
Report
5
 REVISION HISTORY -1 5
ABBREVIATION-2
PURPOSE -3
OPERATORS NAME -4

Batch LINE CLEARANCE -5

REFERENCE AND RELATED DOCUMENTS -6

Record EQUIPMENT -7
CONSUMABLE AND GLASSWARE -8
RAW MATERIALS AND SOLUTION -9
CRITICAL PROCESS PARAMETER -10
PROCESS STEPS -11
 MATERIAL RECONCILIATION -12 5

PRODUCT RECONCILIATION -13

Batch ATTACHMENTS -14

Record DEVIATION AND NON-CONFORMITY DURING THE -15

PROCESS STEPS

OBSERVATIONS -16

AUTHORIZATION -17
 PRETREATMENT-1 5
WEIGHING-2
PREPARATION INTERMEDIATE 1 -3
Example of PREPARATION INTERMEDIATE 2 -4

BPR for X FILTRATION -5

FILLING -6
production STOPPERING -7
CAPPING -8
STORAGE -9
SECONDARY PACKAGING -10
PRINTED MATERIAL -11
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Log books

 Logbooks should be kept for major or critical analytical testing, production equipment,
and areas where product has been processed.

 They should be used to record in chronological order, as appropriate, any use of the area,
equipment/method, calibrations, maintenance, cleaning or repair operations, including the
dates and identity of people who carried these operations out.
 Cleaning process should be checked by witness.
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2-Abbreviation
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3-Purpose
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4-Operators Name
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5-Line Clearance
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5-Line Clearance
6-Reference and Related 5

Documents
7-Equipment 5
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9-Consumable and Glassware
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10-Raw Materials and Solution
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11-Critical Process Parameter
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12-Process Steps:

1-Vial washing and Sterilization

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5
5
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Process Steps: -12

2-Filling Process
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13-Material Reconciliation 5
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16- Deviation and Non-conformity during

the Process Steps
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17-Authorization
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Input Output
Critical process parameter
(CPP)

Critical Quality attribute

(CQA)
Critical material attribute
(CMA)
BPR Include:
Batch Review
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Writing style

SOP and BPR is directive documents which describe a process with sufficient detail so that someone with limited
experience or knowledge, but with a basic understanding, can successfully reproduce the procedure when
unsupervised.

Don`ts Do`s

Good ‫خوب‬ Three time/till to be clear ‫تـــ شفـاف شـدن‬

‫ ا‬/‫بــــ‬
‫ار‬ ‫سـهـ‬

Enough ‫افی‬
‫کـــ‬ X to y minutes/hours ‫ ساــعت‬/ ‫دـقیقهـ‬

Sufficient ‫افی‬
‫کـــ‬ X time

If required ‫اشد‬
‫اگر الــزم بــــ‬ When … it is required

According to procedure ‫مطابـق دـستورـلاــعمل‬ Based on SOP XX-YY-001

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Data entry

 Shall be done at the time of action not be made prospectively or retrospectively.

 Use indelible blue ink.

 To be clear, readable and indelible

0 6
U V

(102 ≠ 1.2) (65 ≠ 6S) (9/5 ≠ 9.5) (4B ≠ 48) S 5

1 7
3 8
B 8
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Data entry – cont.

 Entries for checks shall be mentioned as complies if within spec limits/ satisfactory in case for
observations. Do not mention as okay / good.
 Don’t Use of ditto marks (“) Data should be congruent with limit

 5.96
Limit: 5.50-6.00 Result: 6.0 6.04
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3- Data entry – cont.


Use defined format for date and time 14:35, 1399/12/10, 2021-03-17 (YYY-MM-DD)

 For electronic data, only authorized persons should be able to enter or modify data in the computer, access should
be restricted by passwords.
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Error Correction

Correction of documentation errors should include:

 Draw a single line through the error, so that the original records are always visible

 Make the correction next to the error,

 Write an explanation for the error,

 Sign and date the correction.

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Example of correction

 Correction performed immediately after the error was made.

Weight 56.5 mg Sina 1399/12/21
65.5 mg Sina
1399/12/21
 Correction performed the day after the error was made.

Weight 56.5 mg Sina 1399/12/21

65.5 mg Transcription error, check the printing
weight

Sina 1399/12/22
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Example of date correction

 Date Correction

1394/12/10 12 Sina NOT CORRECT!

1394/12/10 1394/12/12 Sina CORRECT

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‫دستورالعمل اجرایی استاندارد(‪)SOP‬‬

‫‪‬سندی است که دـر موردـ نحوه انجام فعالیتها تهیه شده و تضمین کننده‬
‫یکنواختی انجام کار است‬
‫‪‬قسمتهای مختلف ‪:‬‬
‫‪‬سربرگ‬
‫‪‬متن‬
‫‪‬ته برگ‬
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‫دستورالعمل اجرایی استاندارد(‪)SOP‬‬

‫سربرگ‬
‫‪‬نام و لوگوی شرکت‬
‫‪‬شماره ‪SOP‬‬
‫‪‬نوبت چاپ‬
‫‪‬صفحه بندی‬
‫‪‬عنوان‬
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‫دستورالعمل اجرایی استاندارد(‪)SOP‬‬

‫متن‬
‫‪‬هدف‬
‫‪‬کاربرد‬
‫‪ ‬مسـئولیت‬
‫‪‬مالحظات ایمنی‬
‫‪ ‬دستگاهـها‬
‫‪‬مواد و معرفها‬
‫‪‬اقدامات اوـلیه‬
‫‪‬روش کار‬
‫‪‬مراجع‬
‫‪‬پیوست‬
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‫دستورالعمل اجرایی استاندارد(‪)SOP‬‬

‫ته برگ‬
‫‪‬نام ‪ ،‬سمت و امضای تهیه کننده با تاریخ‬
‫‪‬نام ‪ ،‬سمت و امضای بازنگری کننده با تاریخ‬
‫‪‬نام ‪ ،‬سمت و امضای تصویب کننده با تاریخ‬
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SOP

 Example of SOP
Retention
Good Documentation Practices
DOCUMENTS IMPORTANCE
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Why are documents so important?

EU, PIC/s GMP chapter 4, WHO GMP chapter 15:

1-Good documentation is an essential part of the QA system and key to operation

in compliance with GMP requirements.
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Why are documents so important?

21CFR 211.180(e):

2-Written records…shall be maintained so that data therein can be used for evaluating…the quality
standards of each drug product…“

Documents provides the route for auditors to assess the overall quality of operations and the final product.
Purpose of documentation
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Purpose of documentation

 To define specifications and procedures for all materials and methods of manufacture and
control
 To ensures all personnel concerned with manufacture, know what to do and when to do it
 To ensure that authorized persons have all information necessary for release of product
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Purpose of documentation

 To ensures documented evidence, traceability, provide records and audit trail for investigation
 To Ensures the availability of data for needed for validation, review and statistical analysis
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Purpose of documentation

EU, PIC/s GMP chapter 4:

-The main objective of the system of documentation utilised must be to establish, control,
monitor and record all activities which directly or indirectly impact on all aspects of the
quality of medicinal products.

-There are two primary types of documentation used to manage and record GMP
compliance: instructions (directions, requirements) and records/reports.
.
DOCUMENTATION PREPARATION
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1- Preparation

 To be designed, prepared, reviewed and distributed with care

 To be approved, signed, and dated by the appropriate competent and authorized persons. The effective

date should be defined

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1- Preparation Cont.

 To have clear/unambiguous contents and be identifiable. (e.g. title, nature, and purpose)

 Instructions style to be in the imperative (Mix, Wash, Do, Add, etc.)

 Short and simple sentences preferred to long, florid sentences

 Sufficient space must be provided for such entries

 Not be handwritten
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Standard Operating Procedure

 Scope: Very important section as it informs the person what a particular SOP does and
does not apply to.

For example:
Measurement of solution concentration using Agilent HPLC for in process control.
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Standard Operating Procedure

 Responsibility: Who is responsible for performing and supervising the SOP.

 Safety: Specifies all requirement for safe operation including operator,

equipment, environment

 Equipment: Specifies all required equipment with ID number, required number if

applicable

 Material: Specifies all required material with ID number, required amount

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Standard Operating Procedure

 Preliminary operation:
is optional and may or may not be relevant to the SOP such as:

A check list to ensure all the relevant materials required for the procedure are assembled prior to starting

The sanitization of biosafety cabinet before starting a procedure.

Preparation of fresh solution

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Standard Operating Procedure

 Abbreviation:Specifies all mentioned abbreviation in the all section

 Reference: Specifies all required and mentioned reference including the other SOPs and
records
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Standard Operating Procedure

 Procedure:

1. -Simple and short

2. -Clear and instructive
3. -A step by step in an orderly / sequential manner
4. -Accurate, Informative
5. -Using picture, tables, and simple diagrams and an example may speak a 1,000 words
6. Confirm compliance with cGMP
7. -Critical Parameter
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Standard Operating Procedure

-In process control

-Storage condition (container, temperature, time, caution)