GMP Standard Operating Procedures (SOP)

Quality Assurance (QA) Management Procedures

Writing Standard Operating Procedure

Standard Operating Procedures (SOPs) are issued to specifically

instruct employees in areas of responsibility, Work Instructions,
appropriate specifications, and required records. SOPs outline
procedures that must be followed to claim compliance with
GMP principles or other Statutory rules and regulations.

Procedures can take the form of a narrative, a flow chart, a

process map, computer screen printouts, or a combination of
all or any other suitable form; however, they must be written in
appropriate, effective grammatical style. (e.g., plain English).

Classification of GMP Documents

In this SOP, you will find all types of quality and

Technical/Master file records to build up a top-quality
management system for your production sites, a description of
documents & records, their distinction, acceptance
requirements, and storage specifications. This process has
schematic blueprints for your knowledge of how different types
of records are prepared and saved in a common data source.

Quality Documentation Change Control

This procedure describes the role of manufacturing personnel in

creating and reviewing/updating Quality Documentation,
Document Control Officers, and File Administrators. All
personnel involved in the manufacturing activities are required
to read Quality Documentation and are responsible for creating
and updating procedures when required.

Documentation Rule

There are many different reasons for the creation and

maintenance of GMP documentation. GMP documents are
required for one or more of the following reasons:

– Keep track of activities

– Create legal documents

– Provide a historical record

– Provide information

– Comply with regulations.

Document Control

A request to initiate the new document is received via a

completed, signed Form 505. See QMS – 010 for the definition
of document types and data required for each type. The
Document Administrator is to:

Issue a document number from the Documentation Database.

See SOP QMS – 015 for the SOP numbering system.

Raise a new record in the “Quality Documents” area of the

Database. See Appendix 1 for a flowchart describing the process
for raising a new record.
Complete file properties for the document to be created in the
database. Type in the Status box “To be Written” the author’s
name and the date the record was added.

Master GMP Documents

Encompasses all documentation required for the manufacture

and release of a product. The Master File encompasses both in-
house and regulatory documentation, a description of which is
detailed in this SOP.

Deviation Reporting

A deviation is a departure from standard procedures or

specifications resulting in non-conforming material &/or
processes or where there have been unusual or unexplained
events that have the potential to impact product quality, system
integrity, or personal safety. For compliance with GMP and for
the sake of continuous improvement, these deviations are
recorded in the form of a Deviation Report (DR).

Product Shelf Life

The shelf-life calculates the Expiry Date for products
manufactured/packed at a GMP site. Shelf Life means the
number of months or years for which the product will meet the
label claim, plus a safety margin when packed and stored as
specified.

Vendor Selection and Evaluation

The process of vendor assessment and evaluation is divided into

four phases.

Vendor Assessment
Phase 1. Technical discussions
Phase 2. General Vendor Audit
Phase 3. Item specific evaluation

Vendor Evaluation
Phase 4. Ongoing vendor evaluation

Vendor Certification
Certification – “Is the act of approving quality control testing
results provided by the supplier in relation to a specific
material, thus eliminating the need to undertake some or all
laboratory tests on receipt of that material unless specifically
required to meet regional/local GMP and/or regulations”.

Product Complaint

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 severe or life-
threatening health situation.

Serious Complaint: A complaint that indicates the purity,

identity, safety, or efficacy of a product may have been
compromised but does not present as a severe or life-
threatening health risk.

Standard Complaint: A complaint that is neither critical nor

serious.

Periodic Product Quality Review

The annual product quality review will determine the need for
re-validation of processes or methods, changes in product
specifications, manufacturing and control procedures, as well as
evaluation of the need for regulatory notification supplements
to regulatory submissions

Rework

In-Process Manufactured Goods: Re-inspection / Rework of In-

Process Manufactured Goods due to a possible defect in all or
part of the BPN (Batch Production Number). The batch number
will not be changed.

Manufactured Finished Goods (MFG) Rework: Conversion of a

product from one Batch Number to another. Re-inspection /
Rework of Manufactured Finished Goods due to a possible
defect in all or part of the BPN.

Rework of Product at Contract Manufacturer: Reinspection /

Rework of Manufactured Finished Goods due to a possible
defect in all or part of the BPN at an External Contract
Manufacture site.
Product Identification and Traceability

A product traceability system allows for complete and up-to-

date histories of all batches of products from the starting
materials to the complete final product. Identification and
status of materials are provided by a unique and controlled
numbering system. The system can be interrogated to provide
reports to allow for full traceability.

GMP Audits

An audit is a systematic and independent review to verify

compliance, suitability, and/or data integrity. Audits may assess
systems, processes, procedures, facilities, products, records,
and/or data for compliance with policies, standards,
procedures, guidelines, regulations, or regulatory submissions.

Batch Documentation

An authorised production operator has to ensure all

appropriate Batch (BPN) relevant records have been reviewed
for completeness and included in the Batch Documentation.
Production operators have to print out the appropriate “Batch
Documentation Checklist” Form for the Process being
manufactured, complete the Production section of the
Checklist, and include it at the top of the Batch Documentation.
Process managers have to ensure an effective process of Batch
Documentation collection. QA staff must collect the batch
documents and retention samples for QA Evaluation.
Laboratory staff have to collect the test samples for laboratory
analysis.

Batch Document Evaluation for Release

Batch documents: A collection of all relevant documents,

including MI sheets, generated throughout the manufacturing
process of a particular batch. It also includes samples of printed
cartons, leaflets, shipper labels, and Line clearance/Opening
forms collected altogether.

GMP Training

All manufacturing employees are required to attend a formal

GMP Induction training program at the commencement of
employment as an introduction to the principles of Good
Manufacturing Practices. To ensure continued knowledge of
current GMP requirements, Manufacturing staff is required to
undertake GMP education on an ongoing basis. The GMP
Maintenance Education Points System is a means of ensuring
this.

GMP Training Materials

Training materials play a vital role in ensuring that staff are fully
competent to perform tasks in a manner that minimises risk to
themselves, others, products or company equipment.

House Keeping Audit

The level of Housekeeping is an indication of someone’s

attitude towards GMP and Quality. This means:

– Thinking of SAFETY FIRST.

– Thinking GMP COMPLIANCE

– Wearing uniform and hairnet correctly.

– Minimizing the amount of equipment kept in areas.

– Do not clutter areas with unnecessary items or personal

belongings.

– Emptying bins and removing waste.

Contract Work

cGMP and all aspects of this procedure must be adhered to to

ensure the production of a quality product. Separate
documentation is to be prepared for each presentation of each
type of product, but repeat operations are referenced to the
original documentation as long as there has been no change in
the items listed. However, any changes to established contract
work are to be handled in a similar manner to new contract
work.

Raw Material and Packaging Components Sourcing

The aim of this SOP is to define a manufacturer and vendor,

detail selection criteria and selection procedures, and provide
details for the assessment of manufacturers and processes for
approval of the manufacturers.

Quality Investigation Process

A batch record comment is a minor event, which is something

that is expected to occur, is usually isolated to a single batch,
the cause is known with certainty, no follow-up action is
required, and is non-recurring within a short period of time. For
example, line stoppages at certain times, etc

Change Management System

All departments requiring a planned permanent change to a

GMP system are bound by the rules set out in this procedure.
This SOP applies to any change affecting product quality,
regulatory filings, data integrity, or environmental health and
safety.

Cross-functional investigation

The Scope of this SOP covers Cross-Functional Investigations

(CFI), also known as extended investigations. CFIs are raised
when a deviation occurs or there is a complaint trend, annual
product review trend, or trend in any other quality aspect
identified by a quality system.

This SOP does not cover Continuous Improvement

Projects/Investigations that have been identified and are not
related to a Deviation or any other Quality Failure or Trend