Training Program on

Complaints, Recall, Rejection & Re-Process of

Material

Complaints, Recall, Rejection & Re-Process of Material

Complaints, Recall, Rejection & Re-Process of Material: Applicable Guidelines

ICH HARMONISED TRIPARTITE GUIDELINE

GOOD MANUFACTURING PRACTICE GUIDE FOR

ACTIVE PHARMACEUTICAL INGREDIENTS

Complaints, Recall, Rejection & Re-Process of Material

Scope:

The scope of this presentation is to address the Complaints, Recall, Rejection

& Re-Process & Rework of Material.

Complaints, Recall, Rejection & Re-Process of Material

Regulatory Prospective:

ICH Q7

t Coral Drugs Pvt Ltd

Section 2.2

Quality unit should be responsible for making sure

that quality related complaints are investigated and

resolved.

Quality assurance is responsible for overall

implementation of complaint

SOP #CDPL/SO/QA/009/10 , involve in investigation,

suggest CAPA, adequately close and resolve the

complaint.

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 2.5

Product Quality Review

A review of all quality

-related returns, complaints

and recalls.

Market complaints and return are reviewed during

product quality review. Refer section 6.2

SOP# CDPL/SOP/QA/019/06

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 10.11

Separate storage area should be assigned to

returned or recalled material.

Returned goods should be kept in designated

rejected area by maintaining proper storage

condition.

Refer section 4.1

SOP# CDPL/SOP/QA/049/05

Recall material must be kept in rejected room under

lock and key.

Refer section 4.1

SOP# CDPL/SOP/QA/012/07

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 11.11

There should be documented procedures

describing sampling, testing, approval or

rejection of materials.

Rejection of material is handled to through

SOP# CDPL/SOP/QC/024/10

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 14.20

Introduction an intermediate or API, including one

that does not conform to standards or specifications,

back into process and reprocessing by repeating a

crystallization step or other appropriate chemical or

physical manipulation steps (e.g. distillation, filtration,

milling) that are part of established manufacturing

process is considered acceptable for reprocessing.

Reprocess is, introducing an intermediate or API,

back into the process and repeating a crystallization

step or other appropriate chemical and physical

manipulation steps (e.g. distillation, filtration,

column) that are part of the established

manufacturing process. (Section 6.1)

SOP# CDPL/SOP/QA/027/08

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 14.3

Before a decision is taken to rework batches that do

not confirm to established specifications, an

investigation should be performed.

Any batch of intermediate or finished product is

rejected, after investigation and decision is made to

rework the batch. (Section 6.2.1 & Section 6.2.2)

SOP# CDPL/SOP/QA/048/04

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 14.31

Batch that have reworked should be subject to

appropriate evaluation, testing, stability testing if

warranted.

If there is only one batch to be reworked, then report

can be written and the batch released once it is found

to be acceptable.

The rework batches may be released for commercial

purpose, if quality of such batches is similar to the

normal production batches and results of stability

If there is one batch to be reworked then interim

report will be prepared and the batch released, if it is

acceptable (Section 6.2.10 & Section 6.2.13)

SOP# CDPL/SOP/QA/048/04

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 14.32

Procedures should provide for comparing the impurity

profile of each reworked batch against batches

manufactured by established. Where routine analytical

methods are inadequate to characterize the reworked

batch, additional method should be used.

Impurity profile of re

-worked batches shall be

compared with validation batches. Quality control will

supports any additional testing required to ensure

integrity of the reworked material. (Section 6.2.13 &

Section 6.2.14)

SOP# CDPL/SOP/QA/048/04

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 14.50

Returned intermediates or APIs should be identified as

such and quarantined.

Return goods should be kept in designated rejected

area by maintaining proper storage condition.

(Section 4.1)

SOP# CDPL/SOP/QA/049/05

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 14.51

If the conditions under which returned intermediates

or APIs have been stored or shipped before or during

their return or the condition of their containers casts

doubt on their quality, the returned intermediates or

APIs should be reprocessed, reworked, or destroyed,

as appropriate.

Based on the condition of the material/drums, QA will

decide suitable recommendation. (Section 6.7)

SOP# CDPL/SOP/QA/049/05

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 15.10

All quality related complaints whether received orally

or in writing, should be recorded and investigated

accordingly to a written procedure.

Based on the condition of the material/drums, QA will

decide suitable recommendation. (Section 6.7)

SOP# CDPL/SOP/QA/049/05

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 15.11

Complaint records should include:

Name and address of complaint

Name (and, where appropriate, title) and phone

number of person submitting the complaint;

Complaint nature (including name and batch number

of the API)

Date compliant is received.

Name and address, title, complaint nature, date of

complaint, are recorded on Format No.

CDPL/FR/QA/112

SOP# CDPL/SOP/QA/009/10

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 15.11

Action initially taken (including dates and identity of

person taking the action);

Any follow

-up action taken

Response provided to the originator of complaint

(including date response sent) and

Final decision on intermediate or API batch or lot.

Action initially taken are recorded on Format No.

CDPL/FR/QA/111

SOP# CDPL/SOP/QA/009/10

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 15.13

There should be written procedure that defines the

circumstances under which a recall of an intermediate

or API should be considered.

Procedure for Recall SOP# CDPL/SOP/QA/012/07 is

established that define the circumstances under

which a recall of an intermediate is initiated.

(Section 6.1)

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

ICH Q7

t Coral Drugs Pvt Ltd

Section 15.14

The recall procedure should designate who should be

involved in evaluating the information, how a recall

should be initiated, who should be informed about

recall, and how the recall material should be treated.

Procedure for Recall SOP# CDPL/SOP/QA/012/07 is

established that describe the responsibility complete

information on recall.

Regulatory Prospective:

Complaints, Recall, Rejection & Re-Process of Material

Customer complaints….!!!

(SOP#CDPL/SOP/QA/009/10)

Complaints, Recall, Rejection & Re-Process of Material

• Head-QA/ Designee shall write the complaint product details and categorize the complaint as

Critical/Major/Minor .

• Critical Complaint:

A complaint that strongly indicates the purity, identity, safety or efficacy of a product may have been

compromised and has the potential to cause a life threatening or serious health situation.

• Major Complaint:

A complaint that indicates the purity, identity, safety or efficacy of a product may have been

compromised but does not present as a life threatening or serious health risk.

• Minor Complaint:

A complaint that is neither critical nor serious.

Complaint Category

Complaints, Recall, Rejection & Re-Process of Material

• Based on Preliminary investigation, response shall be sent to the customer with in 15 days.

• Close out of the complaint with complete investigation shall be made within 45 days.

• Incase the investigation time extends beyond the closer time frame, it will be informed to the

customer and justified.

• If customer did not responds within 90 days after getting the investigation report, complaint will be

considered as closed thereafter.

Closure Time Frame

Complaints, Recall, Rejection & Re-Process of Material

Recall Procedure ….!!!

(SOP#CDPL/SOP/QA/012/07)

Complaints, Recall, Rejection & Re-Process of Material

Based on the evaluation, the recall team members shall classify the recall as Class I, Class II and Class III.

Class I Recall:

These are recalls which result from quality defects of medicinal products which are potentially life

threatening or could cause serious risk to health.

Class II Recall:

These are recalls due to quality defects which may cause mistreatment or harm to the patient but it is not

life threatening or serious.

Class III Recall:

These are recalls due to quality defects which are unlikely to cause harm to the patient, and the pose a

significant hazard to health but where a recall has been initiated for other reasons, such as noncompliance

with the marketing authorization or specification.

Recall Classification

Complaints, Recall, Rejection & Re-Process of Material

• Based on the category of risks involved; specific time line is assigned for recall of the product:

• Within 24 hour up to a maximum of 72 hours for class I recall

• Up to a maximum of 72 hours for Class I recall

• Up to maximum of 10 days for Class II recall

• Up to maximum of 30 days for Class III recall

Time lines for effective Recall system

Complaints, Recall, Rejection & Re-Process of Material

Return Goods ….!!!

(SOP#CDPL/SOP/QA/049/05)

Complaints, Recall, Rejection & Re-Process of Material

• Returned intermediates or APIs should be identified as such and Rejection.

• If the conditions under which returned intermediates or APIs have been stored or shipped before or

during their return or the condition of their containers casts doubt on their quality, the returned

intermediates or APIs should be reprocessed, reworked or destroyed, as appropriate.

• Records of returned intermediates or APIs should be maintained. For each return documentation should

include:

• Name & address of the consignee.

• Intermediate or API, batch number and quantity returned.

• Reason for return.

• Use or disposal of the returned intermediate or API.

• Store department shall inform to Quality Assurance through “Return Goods

• Handling form” on applicable format.

• Returned API shall be handled through return goods procedure.

Return Goods:

Complaints, Recall, Rejection & Re-Process of Material

Reprocess Procedure ….!!!

(SOP#CDPL/SOP/QA/027/08)

Complaints, Recall, Rejection & Re-Process of Material

Reprocess is, introducing an intermediate or API, back into the process and repeating a crystallization step

or other appropriate chemical or physical manipulation steps (e.g. distillation, filtration, column) that are

part of the established manufacturing process.

Reprocess:

Complaints, Recall, Rejection & Re-Process of Material

• Reprocessing of intermediate / finished product shall be applicable in following conditions:

• Manufacturing older than 6 months

• To meet the customer special requirements.

• Recommendations after investigation of return goods.

• Recommendation from OOS

• For making a homogenous batch of tailing batches quantity available in finished good store.

Conditions for Reprocessing of Intermediates/Finished Products

Complaints, Recall, Rejection & Re-Process of Material

Rework Procedure ….!!!

(SOP#CDPL/SOP/QA/048/04)

Complaints, Recall, Rejection & Re-Process of Material

Introducing an intermediate or API that does not conform to standards or specifications to one or more

processing steps that are different from the established manufacturing process to obtain acceptable quality

intermediate or API (e.g. recrystallizing with a different solvent).

Re-work

Complaints, Recall, Rejection & Re-Process of Material

• Any batch of intermediate or finished product is rejected, after completion of the investigation as per

the SOP OF handling of out of specification (CDPL/SOP/QA/013), a decision is made to rework by QA.

• If a decision is made to re-work the batch, a “Notification of Re-work” (CDPL/FR/QA/107) is initiated by

Production In-charge.

• The reworked batches may be released for commercial purpose. If the quality of such batches is similar

to the normal production batches and results of stability are satisfactory.

• If there is only one batch to be reworked , then an interim report will be prepared and the batch

released, if it is acceptable.

• Impurity profile of re-worked batches shall be compared with validation batches.

Re-work of rejected Intermediates / Finished Products:

Complaints, Recall, Rejection & Re-Process of Material