prelim 1 - introduction to pharmaceutical manufacturing

Refers to any or all operations involved in the production of pharmaceutical products (except compounding and filling of prescriptions)

Pharmaceutical manufacturing

Production of the API (Stages of pharmaceutical manufacturing)

Stage 1 (Primary manufacturing/processing)

Conversion of the API into products suitable for administration (Stages of pharmaceutical manufacturing)

Stage 2 (Secondary manufacturing/processing)

Is engaged in any or all operations involved in the production of pharmaceutical products (except the compounding and filling of prescriptions)

Pharmaceutical manufacturer

DOH A.O. that covers the revised guidelines on the unified licensing requirements and procedures of the FDA repealing A.O. no. 2016-0003

A.O. No. 2020-0017

PIC/S guide A.O. whose objective is to harmonize good manufacturing practice requirements

A.O. 2012-0008

The main regulatory standard for ensuring pharmaceutical quality; covers all aspects of production of pharmaceuticals

Good manufacturing practice (GMP)

A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality

Quality audit

FDA guidelines for the classification of deficiencies observed during inspection of drug manufacturers

FDA Circular No. 2019-003

A deficiency which has produced or may lead to a significant risk of producing either a product which is harmful to the human or veterinary patient, or a product which could result in a harmful residue in a food producing animal

Critical deficiency

A deficiency that also covers findings of the manufacturer’s or its agent’s commission of fraud, misrepresentation, or falsification of products, records, or data

Critical deficiency

Address the deficiencies, including submission of CAPA plan and objective evidence of compliance not later than __________ calendar days

Thirty (30)

A deficiency which indicate a major deviation from the terms of the marketing authorization/production, PIC/S GMP guide and other internationally accepted standard

Major deficiency

A combination of several “other” deficiencies, none of which on their own may be major, but which may together represent a major deficiency

Major deficiency

A deficiency which cannot be classified as either critical or major, but which indicates a departure from GMP

Other

An essential part of the quality assurance system and is the key to operating in compliance with GMP requirements

Documentation

A document describing the GMP related activities of the manufacturer (Types of documentation)

Site master file (SMF)

Describe in detail the requirements with which the materials used or obtained during manufacture have to conform (Types of documentation)

Raw materials specifications

Provide detail all the starting materials, equipment, and computerized systems to be used and specify all processing, packaging, sampling, and testing instructions (Types of documentation)

Manufacturing formulae, processing, packaging, and testing instructions

Recording containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product

Master record

A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture

Batch

A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number

Lot

Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture of a batch or lot of a drug may be determined (LCB)

Lot number, Control number, Batch number

Written instructions on the performance of specific activities (Types of documentation)

Standard operating procedures (SOP)

Give instructions for performing and recording certain discreet operations (Types of documentation)

Protocols

Are agreed between contract givers and acceptors for outsourced activities (Types of documentation)

Technical agreements

Provide evidence of various actions taken to demonstrate compliance with instructions (Types of documentation)

Records

Includes the raw data which is used to generate other records (Types of documentation)

Records

Provide a summary of testing results on samples of products or materials together with the evaluation for compliance to a stated specification (Types of documentation)

Certificate of analysis

Document the conduct of particular exercises, projects, or investigations, together with results, conclusions, and recommendations (Types of documentation)

Reports

Defined as a set of health product vigilance activities and interventions designed to identify, characterize, prevent, or minimize risks to health products (Types of documentation)

Risk management plan (RMP)

Owners will not recruit sufficient people to undertake the work (GMP inspection deficiencies)

No quality management manual

Unqualified or inexperienced people are employed in key positions (GMP inspection deficiencies)

Lack of qualified people

Senior staff do not subscribe to the value of validated processes (GMP inspection deficiencies)

Processes not properly validated

Batch documentation is poor; different batch sizes are made in inappropriate equipment (GMP inspection deficiencies)

Poor SOPs or standard batch documentation