STANDARD OPERATING Radiant

PROCEDURE Pharmaceuticals Ltd.

Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

1. Purpose

The purpose of this SOP is to describe about the systematic procedure of QA

activities in Biotech Packaging Area of Radiant Pharmaceuticals Limited for the
product which will be supplied by Roche.

2. Scope

This SOP will be applicable for the Biotech Packaging Area of Radiant
Pharmaceuticals Limited for the product which will be supplied by Roche according
the agreement (LSQA).

This SOP will be effective after approval and training of the relevant personnel.

Effective Date

3. Responsibility

3.1 Authorized QA personnel of RPL are responsible for monitoring the overall
Biotech Packaging activities.

3.2 QA personnel will be participating the visual inspection of the unlabeled vial
along with the production personnel.

3.3 Authorized QA personnel are responsible for issuing of BPR as per requisition
from Production Department.

3.4 Trained QA personnel are responsible for proper IPC checking of the secondary
packaging.

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 1 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

3.5 QA personnel will collect & monitor the storage of Reference Sample &
Retention Sample.

3.6 QA Personnel will ensure that all activities correspond with respective SOPs.

3.7 Head of QA/Designee of RPL is responsible for final release of a batch.

3.8 QA is responsible for all Quality Management System throughout the process.

3.9 Head of QA is responsible for approving the reviewed SOP and implementation
of this SOP.

4. Safety

Not applicable

5. Instruction

Not applicable

6. Description

6.1 Responsibilities on Unlabeled Filled Vial Receiving to Finished

Product Release

6.1.1 Check the storage condition of the Bulk Product & the Packing System of the
product during receiving of the consignment in the receiving bay of RPL
warehouse along with warehouse personnel as per SOP no WH-XXXX.YY).

6.1.2 Monitoring the visual inspection of the unlabeled vial along with the
production personnel. (Annex)

6.1.3 With compliance of the visual inspection of the product (bulk) & identification
test from QC, QA personnel will evaluate the COA of the product (bulk) from

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 2 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

the manufacturer and release the product (bulk) for further manufacturing
(secondary packaging) as per Annex-I.

6.1.4 Authorized QA personnel will be issued the Batch Packaging Record (BPR) as
per SOP no. QA-1010.XX as per requisition of the Production.

6.1.5 Before giving approval to the startup of Secondary packaging, check the
followings:

6.1.5.1 Cleanliness of the packaging room.

6.1.5.2 Room is cleared from previous bulk and packaging materials.
6.1.5.3 Room temperature, relative humidity & differential pressure is within the
specified limit.
6.1.5.4 Correctness of the materials used in the packaging, approval of the
materials.
6.1.5.5 Check all the packaging materials and compare the code number of
materials shown on the label against the Batch packaging record (BPR).
After checking all In-process Control (IPC) activity, record all In-process Control
(IPC) tests parameters on the In-process Control Record Sheet for Secondary
Packaging for Vial in Annex-II.

6.1.6 Following points to be checked during secondary packaging operation-

6.1.6.1 Confirm that the vials are free of visible defects (e.g., cracks, chips, or
cloudiness).
6.1.6.2 Check that vial caps and seals are intact and properly seated.
6.1.6.3 Printing on Vial label – Batch no., Mfg. date, and Exp. date.
6.1.6.4 Printing or embossing on inner carton - Batch no, Mfg. date & Exp. date.
6.1.6.5 Printing on shipper label – Batch no., Exp. date.

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 3 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

6.1.6.6 Check the number of Vial/Vials per inner carton.

6.1.6.7 Presence of additional accessories in inner carton (if any).
6.1.6.8 Check the sticking of hologram/ cellulose tape (with logo) on inner carton.
6.1.6.9 Check the code number of vial label, shipper label, inner carton,
leaflet, additional leaflet, Master carton, shipper carton, liner etc. where
applicable.
6.1.6.10 Check the number of packs per shipper carton as per BPR & also check it
in shipper label.
6.1.6.11 Check the weight of one filled inner carton/ shipper carton as and
when required.
6.1.6.12 Collect the QC Sample (if required) & retention sample as per BPR.
6.1.6.13 Check the secondary packing line initially at the start of the
packaging/starting of each day (if the batch continues for more than one
day). Continue the checking at least every two hours’ interval or at least
three times through the process (as start, middle & end).
6.1.6.14 At the end of batch processing, trained and qualified QA personnel
shall inspect all parameters and document the appropriate information on
the Finished Product Inspection Sheet for Vial in Annex-III.

6.1.7 After COA from QC & COC from Production, QA will review the batch
document & having compliance of all relevant data; release the product as
per SOP no. QA-1041.XX.
6.2 Quality Management System (QMS)

Quality management system (QMS) is the process, system and activities that
enable the development, manufacture, registration, commercialization of high
quality pharmaceuticals products.
Elements of Quality Management System-
• Document Control, Achieving & Retention

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 4 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

• Training Management
• Internal Audit/ Self Inspection
• Product Complaints & Potential Counterfeit
• Product Recall
• Change Control System
• Quality Risk Management (QRM)
• Deviation Management
• Corrective Action and Preventive Action (CAPA)
• Out of Specification (OOS) Management
• Annual Product Quality Review (APR/ APQR)

6.2.1 Document Control, Achieving & Retention

Radiant need to retain, archive all GMP & QMS related document for a period
covering at least fifteen years from the date of manufacture.
All the GMP & QMS related document control, management, archival,
retention and destruction of documents and records are maintained as per
SOP no. QA-1018.XX.
Prior to any destruction of any GMP relevant documents and records Radiant
must request Roche‘s written approval. According to Roche‘s written
response, Radiant may destroy those documents and record(s) or Radiant
will retain the documents and records for an additional agreed period or
concerned manufacturing record(s) must be transferred to Roche.

6.2.2 Training Management

All the GxP related task, personnel involving in each field of activity must
have to ensure training. Also Training required for development of personnel
in order to enable them to perform their duties as per GMP requirements.
Both parties (Roche & Radiant) can performed training for sharing knowledge
each other as per agreement. All the training program in RPL are conduct as
per SOP no. QA-1038.XX.
6.2.3 Internal Audit/ Self Inspection

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 5 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

Audits are a valuable tool for evaluating QMS effectiveness, along with
regulatory inspections. To carry out an internal quality audit to determine
whether the quality management system has been effectively implemented
and maintained and conforms to GMP requirements, RPL performs internal
audit yearly twice. A cross-function team performs the internal audit leaded
by head of QA. An audit report is prepared based on audit observations.
Recommended CAPAs are taken based on the audit observations. RPL has a
written SOP for internal audit & audit has been performed as per SOP no. QA-
1040.XX.

6.2.4 Product Complaints & Potential Counterfeit

6.2.4.1 Product Complaint

Both parties (Roche & Radiant) will be handle & share each other complaints
originating from patients, pharmacists and other healthcare professionals,
wholesalers, Health Authorities of Govt., etc.
If a customer Complaint is directly related to Product (Bulk) and/or Product
(Finished), it will be brought to the attention of Roche within one (1) Business
Day for potential Critical Complaint and three (3) Business Days for all other
quality related customer Complaint.
The investigation of all Complaints will be finalized within 30 Business Days,
upon receipt. If the specific investigation cannot be finalized within
30 Business Days, the complaint must be tracked and managed
appropriately and an interim report will be provided.
For handling of product complaint, which ensures that all product complaints
are properly and adequately received, investigated, documented and
responded to complainant in a timely manner RPL has a written SOP (SOP
No. QA-1034.XX).

6.2.4.2 Potential Counterfeit

For Potential Counterfeit of any product Roche and Radiant will inform each
other as soon as practically possible or within three (3) Business Days. Both

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 6 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

parties will be work together to investigate any potential and/or confirmed

counterfeit or diversion.

For confirmed counterfeits of Product (Finished), Radiant will have the

responsibility to perform all related activities in order to remove counterfeit
Product (Finished) from the Distribution Chain and shall be responsible to
take actions against diversions.

6.2.5 Product Recall

Roche and Radiant will co-operate in the event of Product (Finished) Recall or
a possible need to Recall Product (Finished). This means both parties must
support each other with the necessary and sufficient personnel resources
needed to meet required regulatory reporting timeframes for all related
investigations as a result of a potential or actual Product (Finished) Recall.
Radiant will notify Roche in writing within one (1) Business Day of any
Product (Finished) Recall whenever such a decision is made and take over
the responsibility for all related Recall activities.
Roche will notify Radiant in writing within one (1) Business Day of any Recall
decisions taken that is impacting Product (Bulk), delivered by Roche to the
Radiant.
RPL shall perform Product (Finished) Recall in the territory and to inform the
appropriate Regulatory Authority as per SOP no. QA-1033.XX.

6.2.6 Change Control System

As per Agreement Both parties (Roche for Bulk Product & Radiant for
Finished Product) will notify each other for their any kind of major changes.
All major changes notification must be assessed and shared within ten (10)
Business Days. All major changes can be implemented only after the written
approval. Parties have the rights to reject any major changes with a proper
written justification.

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 7 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

In order to evaluate, approve and implement the changes properly, RPL has
established a written SOP to control and manage the change effectively. RPL
shall control all changes as per SOP no. QA-1003.XX.

6.2.7 Quality Risk Management (QRM)

QRM is a systematic process for the assessment, control, communication and

review of risks to the quality of the medicinal product. Both parties will
implement and maintain a system for quality risk management to identify,
manage and mitigate the risks associated with all systems, processes,
materials, equipment and facilities. To handle the QRM, RPL has a written
SOP (SOP no. QA-1028.XX).

6.2.8 Deviation Management

Both parties (Roche & Radiant) need to maintain appropriate procedures for
the identification, investigation, reporting, tracking, trending and closure of
Deviation.
RPL must document and notify Roche’s quality contact of Deviations that are
significant for the Product (Bulk) and Product (Finished), no later than one (1)
Business Day after their detection.
To evaluate & define the requirement of deviation and its handling
procedures including Investigation of Deviation, Root Cause Analysis and
appropriate Corrective & Preventive action, follow-up with addressing the
responsibilities and timeline, RPL has a written SOP (SOP no. QA-1006.XX).

6.2.9 Corrective Action and Preventive Action (CAPA)

Both parties (Roche & Radiant) need to implement their appropriate

Corrective Action & Preventive Action (CAPA) for avoiding future
reoccurrence. For implementation & Follow-up regarding CAPA, RPL has a
written SOP (SOP no. QA-1007.XX).

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 8 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

6.2.10Out of Specification (OOS) Management

RPL assigned personnel performs testing activity of raw materials, in-process

and finished products as per approved specifications. If any test result of raw
materials, in-process and finished products goes out of specification, then
RPL handles the out of specification as per written SOP (QA-1045.XX).

6.2.11Annual Product Review (APR)

Both parties (Roche & Radiant) need to prepare Annual Product Review (APR)
for each product as per GMP requirement. Radiant need to prepare APR
including all Manufacturing, Storage, testing, and release activities
conducted by Radiant for each Product (Finished). Also, Roche will prepare
an Annual Product Error: Reference source not found Review (Error:
Reference source not found) for Product (Bulk) and they will share with
radiant upon request.
For preparation of APR, RPL has a written SOP (SOP no. QA-1020.XX).

7. Definition & Abbreviation

7.1 Definition

7.1.1 Training

Training is teaching, or developing in on self & others, any skills & knowledge
or fitness that relate to specific useful competencies. Training has specific
goals of improving one’s capability, capacity, productivity & performance.

7.1.2 Audit

Audit means an appraisal that demonstrates the degree of adherence to pre-

defined criteria and results in a judgement. Examples are Audits of systems

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 9 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

and documentation. Audits are typically performed by someone not involved

in the activity being audited in order to give the Audit a degree of
independence.

7.1.3 Business Day

Business Day means a day on which a party’s offices are open for business,
(usually any day except Saturday, Sunday, Friday and legal holidays).

7.1.4 Product Complaint

Complaint is information received from an internal or external customer

expressing the dissatisfaction about the standard of service or QUALITY
concerning a delivered Product (Bulk) or Product (Finished) that may be
related to the identity, strength, efficacy, purity or any other defect
described in established standards.

7.1.5 Deviation Management

Deviation means a departure from procedures, regulatory requirements,

Specifications, validated parameters, GMP controlled documents, QUALITY
approved documents, or an unexpected condition related to cGMP activities
for which an assessment is required to determine impact and/or action or
cause of the discrepant event is unknown.

7.1.6 ANNUAL PRODUCT QUALITY REVIEWS (APQR)

APQR means reports that demonstrate the ongoing QUALITY of commercial

products through review and analysis of specified data.

7.1.7 Internal Audit/ Self Inspection

Internal Audit/ Self Inspection means an internal review of any internal

system or function in order to monitor the implementation and compliance

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 10 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

with GMP principles and to propose necessary corrective measures that is

not performed by independent persons.

7.1.8 Product Recall

Product Recall means a tracing and recovery, as far as possible, of every

item of a particular batch or of several batches of Product (Finished) after
they have left the manufacturer to distribution.

7.1.9 Change Control System

Change Control System means any change related to Products, Quality

System or Documentation, Manufacturing Facility, Utility, Equipment,
Chemical Components, API, Manufacturing Process, Packaging, Testing,
Storage, Distribution or Release of Commercial Products through an
approved and controlled process

7.1.10 Corrective Action & Preventive Action (CAPA)

Corrective Action & Preventive Action (CAPA) means a structured process by

which CAPA is systematically identified, implemented, followed-up and
reviewed. CA means an action taken to eliminate or minimize the cause(s) of
an existing non-conformity, defect or other undesirable situation in order to
prevent recurrence.

7.1.11 Quality Risk Management (QRM)

QRM means a systematic process of organizing information to support a risk

decision to be made within a risk management process. It consists of the
identification of hazards and the analysis and evaluation of risks associated
with exposure to those hazards.

7.1.12 Out of Specification (OOS) Management

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 11 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

Out-of-Specification (OOS) means that the test result of the sample does not
meet the accepted established criteria.

7.1.13 Reference Sample

Reference Sample means a sample of a BATCH of Purchased Material,

Product (Bulk) or Product (Finished) which is stored for the purpose of being
analyzed should the need arise during the shelf-life of the batch concerned.

7.1.14 Retention Sample

Retention Sample means a sample from a batch of Product (Finished). It is

stored for identification purposes (e.g., presentation, packaging, labelling,
patient information leaflet, batch number, expiry date) should the need arise
during the shelf-life of the batch concerned.

7.2 Abbreviation

SOP : Standard Operating Procedure

QA : Quality Assurance
QC : Quality Control
R&D : Research & Development
PR : Production
EO : Engineering Operations
WH : Warehouse
PPIC : Production Planning and Inventory Control
RA : Regulatory Affairs
GMP : Good Manufacturing Practice

8. Reference

8.1License, Supply & Quality Agreement (LSQA)

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 12 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable
 STANDARD OPERATING Radiant
PROCEDURE Pharmaceuticals Ltd.
Tongi, Bangladesh
TITLE QA Activities in Biotech Distribution
Packaging Area 1. QA
2. IPC-5F (B-1)

8.2In-House.

9. Change History
Versio Date of
Reason for change
n Issue
November,
01 New
2024

10. Attachments

10. Annex–I : Secondary Packaging In-process Sheet for Vial.

1
10. Annex–II : Finished Pack Inspection Sheet for Vial.
2
10. Annex– :
3 III
10. Annex– :
4 IV
10. Annex– :
5 V
10. Annex– :
6 VI

Originated by: Reviewed by: Approved by: SOP No.:

QA-XXXX.YY
Asif Ahmed Mohammad Jahid Sharmin Ferdousi
Sr. Officer, QA Hossain GM, QA
Manager, QA
Date: Date: Date: Page 13 of 13
Version: 01 Date of Issue: Supersede no: Not Valid up to:
November, 2024 Applicable November, 2027
Approved Date: Not
Applicable