SOP for Label Control and Status Labels in Manufacturing

In short: This example SOP lists the status labels used on equipment, areas, containers and materials in a manufacturing plant, and who is responsible for applying and checking them. It is a template to adapt to your own quality system. Note that regulators also control product labels and printed packaging, which are covered separately below.

“Label control” covers two different things, and mixing them up is a common source of gaps in SOPs. Status labels tell staff what condition equipment, an area or a material is in (cleaned, under maintenance, rejected). Product labels and printed packaging materials carry the legal information on the pack and need much stricter control, because a mix-up can reach a patient.

What the regulators expect

Status labelling. EU GMP Part I Chapter 5 (5.21) lists cleaning status labels on equipment and areas, together with detailed cleaning records, among the measures to prevent cross-contamination.
Printed packaging materials and labels. Chapter 5 (5.46) asks for particular attention to printed materials: store them securely to exclude unauthorised access, keep cut labels and other loose printed materials in separate closed containers, and issue them only to authorised personnel under an approved, documented procedure. Each delivery or batch gets its own reference number (5.47), and outdated or obsolete printed material is destroyed and the disposal recorded (5.48).
Packaging line. Before packaging starts the line is cleared of previous products, materials and documents, using a checklist (5.50). The product name and batch number are displayed at each packaging station (5.51), materials are checked on delivery to packaging (5.52), and a significant reconciliation discrepancy is investigated before release (5.61). Unused batch-coded materials are destroyed and recorded (5.62).
US FDA. 21 CFR 211.122 requires written procedures for receipt, storage and testing of labelling, separate and identified storage for each product, restricted access, rejection of non-conforming material and destruction of obsolete labels. 21 CFR 211.125 requires strict control of issued labelling, checking against the master record, reconciliation, destruction of excess labelling that bears lot numbers, and written issuance procedures. 21 CFR 211.130 requires line clearance before use, documented in the batch record, and separation of packaging operations of different products.

Example SOP

This example SOP is an illustration. Label formats and approvals are site choices.

1. Objective

To lay down the procedure for the use and control of status labels in the production area.

2. Scope

Applies to status labels used on equipment, containers, areas and materials at the manufacturing facility. Product labels and printed packaging materials are controlled under the packaging materials and packaging operations SOPs.

3. Responsibility

Authorised designee of the user department: applies and maintains status labels in the department.
Head of the user department: ensures labelling is followed.
Head QA: approves this SOP and the label formats.

4. Procedure

4.1 Types of status labels

Label	When it is used	Annexure
In process	Product is in the production cycle and ready for the next stage; attached to the batch record	I
Under process	Machine, product or area is in operation	II
To be cleaned	Machine, container or area after a processing stage is finished	III
Cleaned	Area, container or equipment cleaned and ready for use; attached to the batch record	IV
Under fumigation	Area is being fumigated	V
Under maintenance	Equipment is with engineering for maintenance	VI
Rejected	Material or equipment not to be used; to be removed or discarded as per procedure	VII
Disinfectant / sanitiser / cleaning agent	Disinfectant, sanitiser and cleaning solutions, for example for punch cleaning	VIII
Excess material returned	Excess material returned from packaging to stores	IX
Use for	Equipment, container or accessories ready for use for a named product/batch	X
Bulk finished product	Bulk released by QC for the next stage or packing	XI

4.2 General rules

Only the current approved label formats are used. Labels are printed or issued in a controlled way, not photocopied or handwritten ad hoc.
Only one status label is displayed on an item at a time. The old label is removed when the status changes.
The label carries the item or area ID, product and batch (where relevant), date, and the signature of the person applying it.
Items labelled “Rejected” are segregated, with access restricted, until disposal is documented.
The designee of the personnel and administration department checks the disinfectant container for the solution and its status label, and records it in the daily log for filling and checking of disinfectant bottles (Annexure XII).
Status labels attached to batch records are kept with the batch record for at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4, 4.11; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

5. Training

Trainer: Head QA or designee.
Trainees: QA, QC, Production, Packaging, Stores, Microbiology and personnel and administration staff.

6. Distribution

Controlled copies to QA, Production, QC, Packaging, Stores, Microbiology and Personnel and Administration; the original stays with QA.

7. Annexures

Annexure I In process; II Under process; III To be cleaned; IV Cleaned; V Under fumigation; VI Under maintenance; VII Rejected; VIII Disinfectant/sanitiser/cleaning agent; IX Excess material returned; X Use for; XI Bulk finished product; XII Daily log for filling and checking of disinfectant bottles.

8. References

EU GMP Part I Chapter 5; 21 CFR 211.122, 211.125 and 211.130; site quality manual.

9. Revision history

Sr. No.	Revision No.	Change control No.	Details of revision	Reason for revision
1	00	-----------	New SOP	New SOP

Frequently asked questions

Is a status label the same as a product label?

No. Status labels show the condition of equipment, areas or materials inside the plant. Product labels are part of the pack and fall under labelling control rules (21 CFR 211.122 and 211.125; EU GMP Chapter 5).

Do status labels replace cleaning records?

No. EU GMP Chapter 5 lists status labels as an addition to detailed cleaning records, not a substitute.

What happens to excess printed labels after a batch?

Unused batch-coded packaging materials are destroyed and the destruction recorded (EU GMP 5.62), and excess labelling bearing lot or control numbers is destroyed under 21 CFR 211.125(d).

References

European Commission, EudraLex Volume 4, EU GMP Part I Chapter 5: Production (13 August 2014, in operation from 1 March 2015), 5.21, 5.46 to 5.52, 5.61 and 5.62.
European Commission, EudraLex Volume 4, EU GMP Part I Chapter 4: Documentation, 4.11.
21 CFR 211.122 Materials examination and usage criteria; 211.125 Labeling issuance; 211.130 Packaging and labeling operations; 211.180(a) General requirements (records), ecfr.gov.