Manuf Internship Exit Report

download Manuf Internship Exit Report

If you can't read please download the document

  • date post

    27-Nov-2014
  • Category

    Documents

  • view

    109
  • download

    2

Embed Size (px)

Transcript of Manuf Internship Exit Report

Manufacturing Internship at Lloyd Laboratories, Inc.Gilberto Diano Vincent Rebultan Kristina Gayle RodriguezJune 18, 2011

Company ProfileVision-Mission and Core Values

CO MP AN Y PR OF IL E

Founded in Marikina in 1989 Corporate turnover of $10,000,000 Manufacturing facilities in Bulacan and Quezon City in the Philippines and in India (Lloyd Laboratories, Private Limited) Major player in the pharmaceutical industry in the Philippines and in India

VI SI ON

To support our marketing partners with the latest innovations in Pharmaceutical technology To become a global leader as a manufacturer of health care products by providing solutions and alternatives, To uplift the health and well-being of people.

MI SS IO N

To utilize the latest technology and provide significant added value to our partner To build a diverse, productive and challenging workplace To achieve market leadership in all segments of our product line

CO RE VA LU ES

We live, breath and exist in pursuit of products and services aimed at improving life. We exemplify honesty and integrity in all our actions. We are committed in taking care of our people and in giving them the opportunity to grow, to develop and to continuously exceed themselves. We accept and take on our social responsibility to the community we belong to. We believe in the higher purpose of things, to the greater responsibility of our existence and to the real reason for our being.

uality Policy and ISO rtification roducts and Services

QU AL IT Y PO LI CY

Strict adherence to USFDA, WHO, ISO and other statutory cGMP guidelines such as : TGA-Australia (Therapeutics Goods Administration) UK-MHRA (United Kingdom Medicines & Healthcare Products Regulatory Agencies) MCC-South Africa (Medicines Control Council) ANVISA-Brazil (National Health Surveillance Agency) INVIMA-Colombia (National Institute for the Supervision of Foods and Medications)

QU AL IT Y PO LI CY

Providing quality products and services that meet National and International Standards Routine training, effective communication and team building Continual upgrading of technical and quality systems

IS O CE RT IF IC AT IO N

ISO Certification 9001:2000 December 17, 1998 The ISO 9001:2000 standard provides a tried and tested framework for taking a systematic approach to managing the organizations processes so that they consistently turn out product that satisfies customers expectations

PR OD UC TS & SE RV IC ES

Toll Manufacturer PharmaceuticalAnti-infectives (e.g. Co-Amoxiclav, Anti-TB drugs), Analgesic, Anti-HPN, Antacid, Antidiabetic

CosmeticsPerfumes (e.g. Tupperware, ), Detergent Powder, Lubricant (Bliss), Facial cream (Placenta)

HerbalTablets, capsules, Tea (e.g. Liveraide, Taheebo, Jimms )

PR OD UC TS & SE RV IC ES

Contract Packaging Secondary/Re-packaging of drugs manufactured by other companies and imported from other countriesSilver Sulfadiazine (Flammazine) Solvay Pharma Glucophage XR (Metformin) Merck

Organizational Structure Plant Layout and Facilities Equipment

OR GA NI ZA TI ON AL ST RU CT UR E

President Vice President Chairman Plant Manager AVPManuf I, Manuf II Cosmetics QA QC Materials Management

ORGANIZATIONAL STRUCTURE

ORGANIZATIONAL STRUCTURE

P LA N T LA Y O U TPenicillin Cold Storage A4 Blister Making Cefalexin Warehouse (CSI) Warehouse 2

Warehouse 1Cool Room (1) Dispensing (2) QA (1) Solids (2) Liquids & QC (3) Cosmetics

Gym

(1) Canteen (2) Offices

GR2 Clinic & Offices

GR1 GH

FA CI LI TI ES

Manufacturing I

Compounding and packaging area for nonpenicillin pharmaceutical products Solids Uncoated & coated tablets, capsules, pellets Liquids Syrups, solutions, suspensions Class 100,000 Area

FA CI LI TI ES

Manufacturing II

Compounding and packaging area for penicillins & cephalosphorins Solids Uncoated & coated tablets, capsules, pellets Liquids Syrups, solutions, suspensions

Class 100,000 Area

FA CI LI TI ES

Cosmetics Specialist , Inc .

Production and packaging of cosmetics & household products

FA CI LI TI ES

Materials Management

Warehouse; Storage for raw materials, bulk products, packaging materials and finished goods Dispensing Section Batching of raw materials for production Class 1000 Quality Assurance Office Sampling of raw materials Inspection of BP, PM & FG

FA CI LI TI ES

Quality Control

Analysis of raw materials, bulk products and finished goods (both pharma and cosmetic products)

EQ UI PM EN T

ProductionFluid Bed Dryer Gels Cream Mixer Mixing Tanks* Labeling Machine Cartoning Machine Inkjet Printer Blistering Machine Strip Packing Machine Volumetric Filling Machine Ribbon Mixer Sachet Filling

EQ UI PM EN T

Quality Control / Quality Assurance

Digital Caliper and Stokes-Monsato Hardness Tester Atomic Absorption Spectrophotometer Fourier Transform Infrared & Near Infrared* Karl Fischer Titration Apparatus Gas-Liquid Chromatography Moisture Determination HPLC pH Meter Dissolution Apparatus Disintegration Apparatus UV Spectrophotometer Polarimeter Automated Micrometer

Knowledge and Skills Acquired Insights

K N O W L E D G E & S KI L L S A

Inquisitiveness Increased sociability Independence Respect for and camaraderie with all, regardless of position Solidarity Flexibility and hand dexterity Cost-consciousness and speed

IN SI GH TS

Fo rtu n a te to b e g i n th e ch a n ce ve to e va l a te th e va ri u s u o d e p a rtm e n ts O p p o rtu n i to ty vo i o u t co n ce rn s d i ctl to ce re y su p e rvi rs i exi re p o rt so n t T h e va l e o f w o rk Le a rn e d u a b o u t th e h a rd sh i s o f Ll yd p o e m p l ye e s o

(Aside from the fact that there were so many pretty female interns and theres only one Bert)

Problems Encountered

These are excerpts from our Exit Report on the cGMP Evaluation of the Various Departments of Lloyd .

Personnel Professionalism, particularly with regards to the mode of interpersonal communication, must be observed at all times. Inconsistent use of hard hats and safety shoes (Warehouse) Some personnel are not properly clad with required lab attire and safety

Premises Bench in the gowning room is not utilized properly Inadequate space in Liquids Department specifically in Cartoning Line 1 Some employees are not properly clad with their required laboratory gown especially in the compounding area. (Pen) Inadequacy of working space hindering orderly and logical placement of equipment and materials to suit the operation

PremisesMaterials are not properly stored in orderly manner due primarily to inadequate space. They are stored off the floor and not sufficiently spaced. (Warehouse) Materials are not stored under suitable environmental conditions. There is insufficient ventilation and conditions are not monitored.

Sanitation and Hygiene Inadequate practice of hand washing before and after entering the area and absence of (visual) reminders regarding this practice Incomplete protective clothing (e.g. gloves for personnel involving in strip packaging and face masks for the stripping operator). Smoking, drinking, keeping

Sanitation and HygieneThe manual transfer of bulk material from its container to the machine is performed without gloves (CSI) Unassigned operator that manipulate the machine with dirty hands (CSI)

Work ProcessLack of conscientiousness towards the work processOperating with an open wound Dirty packaging materials returned at the assembly line without decontaminating measures (e.g. measuring cup) Rough handling of packaging materials (e.g. amber bottles)

Infrequent use of washing bottle when titrating (QC) Illogical procedure in performing dissolution & UV spec testing (QC)

Equipment Malfunctioning of sealing machine was not addressed immediately resulting in incomplete or burned seals. (Pen) Usage of plastic measuring apparatus (QC) Some machines are rusty Filling machine frequently malfunctions, causing several delays in production

Recommendat ionTo allot less time in packaging and more time in Quality Control and to explore other departments (e.g. PPIC, Arts/Documentation)

END