Pharmaceutical

Regulations
NOM-059-SSA1-2015
Good Manufacturing Practices (Pharmaceuticals)
Talk to: About:
 Quality Dept.  Current operation and requirements
 Purchase Dept.  Future challenges and projects
 Production Dept.  Continuous improvement on warehousing
and distribution
 Distribution Dept.
 Sales Dept.
 Customer / Consumer
Objective. Ensure the minimum requirements for pharmaceutical
manufacturing and logistics process.
Scope. It is mandatory for production and importation sites of
pharmaceuticals for human use, including quality control laboratories,
warehouses and distribution centers for pharmaceuticals and raw
materials.
Definitions.
1. Sanitary Surface Finish (acabado sanitario). It improves
cleanability so equipment and systems maintain sterile.
2. Corrective Action. Planned activity aimed at eliminating the
cause of a deviation or a noncompliance issue.
3. Preventive Action. Planned activity focused on diminishing or
preventing a deviation or noncompliance issue.
4. Warehousing. Storage of raw materials and finished products in
areas with required conditions.
5. Traceability
6. Validation of Cleaning Process
Quality Assurance System
It is the system that contains planned activities focused on ensuring the quality
of pharmaceuticals throughout the entire product life cycle
It includes good practices in documentation, manufacturing, storage and
distribution.
Elements:
1. Quality Manual and Quality Policy
• Information of the product and the process throughout its life
cycle.
• Described production and control operations
• Detailed staff responsibility on the quality system
• Ensure the raw materials and packaging materials come from
approved vendors.
• Quality Agreement. In a buyer-vendor relationship, this
document contains a detailed description of what the conditions
between parties are, defining the operating process, obligations
and responsibilities of each.
• Traceability Process. It outlines the controls along the process
of manufacturing, storage and distribution. These checkpoints
are used to release production batches, to inquiry about process
deviations, and to identify potential preventive actions
• The finished products are stored and distributed maintaining the
quality during its expiration dating period.
2. System Audit and Process of Auditing
• It’s a process that evaluates the quality system effectiveness.
3. Complaint and Deviation Process (CAPA)
• There must be a complaints process and a responsible
4. Continuous Improvement and Change Control. Inquiry about
deviations and failures, perform a root-cause analysis, identify potential
CAPA, evaluate the change impact, monitor the change performance.
5. Recall and Returns Process
6. Documentation Control
7. Risk Management
Chapter 16. Good Storage and Distribution Practices
16.1.1 Overview
This section outlines the control along the logistics process, namely in
WHs, DCs and transportation, in order to keep the quality and integrity
of pharmaceuticals.
16.1.2 Quality System
Quality is not an external, independent activity but it should be
immersed in daily operations, as part of the upper management and
operational staff commitment.
16.4 Risk Management (See chapter 6)
16.5 Staff
16.5.1 Overview
• The distributor should hire qualified personnel.
• The staff should be told about their role, responsibilities, and
relation to other areas, and given a hardcopy of their job profiles.
• There should be a proper staff size according to throughput and
scope tasks. (Is it necessary to include a staff sizing analysis?)
• The staff structure is represented on an organizational chart.

16.1.3 Quality Assurance System 16.5.2 Responsibilities Delegation

• Every distributor and logistics service provider must develop a • The sanitary responsible should appoint any contact person for
(written) quality assurance system: emergencies or product handling out of working hours.
• Detailing the storage and distribution processes, and in what • The sanitary responsible is the ultimate person in charge of the
sequence and how frequent those are reviewed. Including the quality system compliance.
organizational chart, the process flow diagram and its resources, • The sanitary responsible assures the initial and ongoing training.
and the standard operating procedures.
• How do you monitor the efficacy of the quality system? See 16.3
for guidelines, but the critical is to develop a measurement system
using this criteria.
• Traceability. Every activity and transaction should be recorded,
and process issues and deviations as well.
• Complaints and Deviations. (CAPA)
• Improvement and Change Control. How the improvement is
identified, evaluate the change impact that incorporates risk
management, and validate the change before implementation.

16.2 Outsourced Activities

It involves all the outsourced activities such as purchasing, storage,
and transportation of pharmaceuticals
• Evaluate the vendor capacity to perform the activity while
maintaining the quality of the product.
• Define the processes and responsibilities of each party; including
scope, timeliness, resources, communication, and risk assessment.
• Monitor the vendor performance and its improvement process

16.3 Quality System Review

• There should be a review process containing:
• The objectives and targets
• The review frequency
• The performance indicators considering number and
severity of complaints and deviations, product recalls and
returns, CAPA and changes success, risk analysis and